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        "titulo" => "Valoraci&#243;n del grado de coagulaci&#243;n y del factor anti-Xa al introducir el dializador AN69ST&#174; con heparina impregnada"
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    "textoCompleto" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">INTRODUCTION</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">Haemodialysis &#40;HD&#41; systems increase biocompatibility&#44; but we have yet to be able to produce laminar flow which completely avoids system coagulation&#46; The needles&#44; lines&#44; chambers&#44; and membranes of the dialyser have a thrombogenic capacity&#44; which necessitates anticoagulants in order to maintain the patency of the extracorporeal circuit&#46;</p><p class="elsevierStylePara">During dialysis sessions in which anticoagulants are not administered&#44; 5&#37; of cases produce a notable coagulation of the dialyser&#44;<span class="elsevierStyleSup">1</span> which translates into a loss of 150ml of blood occupying the lines and dialyser&#46; For this reason&#44; anticoagulation treatment is administered routinely in patients with no risk of haemorrhage&#44; although substantial disparity exists regarding the criteria used for prescribing it&#46;</p><p class="elsevierStylePara">Traditionally&#44; unfractionated sodium heparin has been used for this purpose&#46; The anti-coagulation properties of this compound are based on the conformational change of antithrombin III and the inactivation of coagulation factors&#44; above all Xa&#46; The effects of administering sodium heparin are immediate&#44; with a half-life of 30 minutes to 2 hours&#46; It is generally administered in boluses&#44; a continuous drip&#44; or through regional heparinisation&#44; and is associated with secondary side effects such as haemorrhage due to excess doses&#44; thrombocytopenia mediated by IgG-heparin immunocomplexes&#44; and thrombocytopenia-associated thrombosis&#46; Other undesirable effects that can appear include hypersensitivity&#44; cutaneous necrosis&#44; and osteoporosis&#46;<span class="elsevierStyleSup">2</span></p><p class="elsevierStylePara">Low-molecular weight heparin &#40;LMWH&#41; provides an alternative for anticoagulation therapy&#46; This drug is obtained by degrading the original heparin molecule into fractions of 4-6kDa&#46; LMWH is used for its lower associated risk of bleeding&#44; since it does not produce an anti-thrombin response&#46; However&#44; it does inhibit Xa&#44; XIIa&#44; and kallikrein&#44; without producing any effect on thrombin&#44; IX&#44; or XI&#46; The half-life of LMWH is longer than normal heparin&#44; which allows for a single dose administered at the start of dialysis that is expressed in anti-Xa units&#46; Although this drug is more expensive&#44; it has fewer secondary side effects on platelet aggregation and thus produces fewer issues with bleeding&#46; The European Best Practice guidelines recommend LMWH as the anticoagulant of choice for dialysis&#46;<span class="elsevierStyleSup">3</span></p><p class="elsevierStylePara">Several different factors can increase the tendency of the circuit for coagulation&#44; such as low blood flow&#44; elevated haematocrit&#44; and high rate of ultrafiltration&#59; in addition&#44; technical errors are an important cause of system coagulations&#46; Isolated clots normally form during HD sessions using routine heparinisation&#46; During the HD session&#44; we can visually monitor signs of coagulation in the dialyser and circuit&#44; such that&#44; depending on the overall aspect of the fibres&#44; we can adjust the anticoagulation dose for the following dialysis session&#46; Laboratory analyses can also aid in assessing the coagulation state of the patient&#44; but not of the circuit&#46; We can measure the number of platelets and bleeding time&#44; which serve to assess primary haemostasis and platelet function&#46; Activated partial thromboplastin time &#40;APTT&#41; measures intrinsic coagulation activity and facilitates an effective control of unfractionated heparin levels&#46; Finally&#44; activated anti-Xa factor is a more sensitive test that allows for controlling coagulation during the use of LMWH&#46;<span class="elsevierStyleSup">4</span></p><p class="elsevierStylePara">In the majority of HD units&#44; these measurements are not normally made&#46; The recommendations regarding dosage are based on body weight&#44; comorbidities&#44; bleeding&#44; and type of HD&#46;<span class="elsevierStyleSup">5&#44;6</span> In patients with a high risk of haemorrhage&#44; it is preferable to use HD without anticoagulation therapy&#44; although the use of polyacrylonitrile dialysers with heparin coating is currently being introduced as an alternative method&#46; The AN69ST<span class="elsevierStyleSup">&#174;</span> membrane design incorporates a polyethylenimine polymer that neutralises polyanionic groups&#44; conferring the capacity for fixing heparin to the surface of the membrane through electric potentials&#46; The AN69ST<span class="elsevierStyleSup">&#174; </span>membrane with heparinisation during the predialysis cleaning phase has low thrombogenicity and does not require saline solution flushes during its use on heparin-free HD&#46; These haemocompatibility results show that the use of this type of membrane is safe and does not increase the risk of massive coagulation for the dialyser and extracorporeal circuit&#46;<span class="elsevierStyleSup">7-10</span></p><p class="elsevierStylePara">We designed a study in patients on a haemodiafiltration &#40;HDF&#41; programme using AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;dialysers without systemic anticoagulation therapy&#44; with the goal of evaluating the variation in patient coagulation parameters&#44; including anti-Xa factor levels&#59; we evaluated the level of coagulation in the dialyser and extracorporeal circuit every hour using a visual scale&#46; Our primary objective was to determine whether differences existed in anti-Xa levels in the absence of differences in terms of massive coagulation between the two groups&#46;</p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">MATERIAL AND METHOD</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">We carried out an experimental&#44; randomised&#44; crossed study including six patients with stage-5 chronic kidney disease on a periodic HD programme for at least six months before&#46; We performed six consecutive sessions of post-dilution HDF using a high-permeability HF80<span class="elsevierStyleSup">&#174;</span> polyethersulfone filter &#40;1&#46;89m<span class="elsevierStyleSup">2</span>&#41; and anticoagulation using standard doses of intravenous nadroparin&#46; In addition&#44; six sessions were administered using AN69ST<span class="elsevierStyleSup">&#174;</span> dialysers using heparin-coated polyacrylonitrile membranes &#40;2&#46;2m<span class="elsevierStyleSup">2</span>&#41; without systemic anticoagulation therapy&#46;</p><p class="elsevierStylePara">Patients and the order of treatment sessions were randomised&#46; All patients signed an informed consent&#46; The study was approved by the healthcare bioethics committee of the Castellon General Hospital&#46;</p><p class="elsevierStylePara">Patients were selected based on the following inclusion criteria&#58; age &#62;18 years&#44; with haemodynamic stability and a life expectancy longer than the predicted duration of the study&#46; Each patient received dialysis treatment three times per week&#44; and had serum albumin levels &#62;3g&#47;dl and haematocrit &#62;30&#37;&#46; We also established the following exclusion criteria&#58; active systemic infectious or inflammatory disease&#44; uncured cancer&#44; haemostasis disorders&#44; or oral anticoagulant treatment at the time of the study&#46; No patients were allowed to receive blood or blood derivative transfusions during the week prior to the study&#44; during the study&#44; or one week afterwards&#46;</p><p class="elsevierStylePara">We included patients with native arteriovenous fistulas or prosthetic fistulas&#46; We also attempted to minimise the differences in blood flow rates in each patient between types of HD&#46; During the study period&#44; neither the duration of HD sessions nor the type of solution used was modified&#44; and the same conventional post-dilution or on-line HDF was used with programmed convection rates&#46; We used the same dialyser during each period and the same anticoagulation dose during the normal dialyser period&#46;</p><p class="elsevierStylePara">Prior to starting each dialysis session&#44; the extracorporeal circuit was purged with 2l heparinised solution at 5000IU&#47;l&#46; Every hour&#44; 100ml of saline solution was infused in order to observe the coagulation level of the dialyser and bubble trap&#46;</p><p class="elsevierStylePara">On the sixth session&#44; in each of the periods&#44; we determined haemogram values in order to evaluate platelet count and haemostasis&#58; prothrombin time&#44; Quick index&#44; APTT&#44; and fibrinogen&#44; and we also measured anti-Xa factor levels&#46; The laboratory analyses were collected at the start of HD&#44; after 2 hours&#44; after ending the session&#44; and prior to the following dialysis session or 44 hours later&#46; We also measured plasma concentrations of urea&#44; creatinine&#44; glucose&#44; sodium&#44; potassium&#44; calcium&#44; phosphorous&#44; total protein&#44; albumin&#44; uric acid&#44; and C-reactive protein at the start of HD and at the end of each session&#46;</p><p class="elsevierStylePara">The dosage for dialysis sessions was measured using the following formulas&#58;</p><p class="elsevierStylePara">&#160;</p><ul><li>Kt&#47;V second generation Daugirdas&#58; Kt&#47;V&#61; &#8211;Ln &#40;&#91;C2&#47;C1&#93; &#8211; &#91;0&#46;008&#42;T&#93;&#41; &#43; &#40;4 &#8211; 3&#46;5 &#42; &#91;C2&#47;C1&#93;&#41; &#42; UF&#47;final weight&#46;</li><li>Kt&#47;V corrected for rebound&#58; Kt&#47;Vr &#61; Kt&#47;V &#42; &#40;1 &#8211;&#160;&#91;0&#46;6&#47;T&#93;&#41; &#43; 0&#46;03</li></ul><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">Samples were sent for processing to the haematology laboratory at the Castellon General Hospital&#46;</p><p class="elsevierStylePara">Samples were extracted for laboratory analyses after each session from 20-25ml of blood taken from the arterial branch after slowing the arterial pump to a flow of 50ml&#47;min during one minute&#44; according to the standard department protocols&#46;</p><p class="elsevierStylePara">We evaluated circuit coagulation every hour using a photographic visual scale with 4 different coagulation levels in the arterial and venous bubble traps&#58;</p><p class="elsevierStylePara">&#160;</p><ul><li>1 &#61; normal&#46;</li><li>2 &#61; fibrous ring&#46;</li><li>3 &#61; clot formation&#46;</li><li>4 &#61; system coagulated&#46;</li></ul><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">The dialyser was inspected every hour until the end of each the dialysis session&#58;</p><p class="elsevierStylePara">&#160;</p><ul><li>1 &#61; normal&#46;</li><li>2 &#61; less than 25&#37; of capillaries coagulated&#46;</li><li>3 &#61; 25-50&#37; of capillaries coagulated&#46;</li><li>4 &#61; dialyser completely coagulated&#46;</li></ul><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Statistical analysis</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">Prior to the study&#44; we calculated the optimal sample size in order to achieve a statistical power of 80&#37; and a 95&#37; confidence interval for paired samples&#46; The sample size was calculated by comparing the two means for anti-Xa factor obtained in studies from the medical literature&#46;<span class="elsevierStyleSup">6&#44;10</span> We also estimated the standard deviation of the mean at 0&#46;1&#44; based on previous studies&#46; We defined Epsilon&#44; which is the minimal difference between means that is considered of practical importance&#44; at 0&#46;2&#46; We estimated that 4 patients would be needed&#44; and taking into account the possible loss of 15&#37; of the study sample&#44; 2 more patients were added&#46;</p><p class="elsevierStylePara">The risk of moderate or severe coagulation events with systemic heparinisation was defined as 5&#37; of sessions&#44; with a noninferiority margin of 10&#37;&#46;<span class="elsevierStyleSup">6&#44;11&#44;12 </span>The unilateral &#945; risk was 0&#46;95&#46; The number of sessions required &#40;result&#41; was 58&#46; The possible loss of patients was estimated at 15&#37;&#46;</p><p class="elsevierStylePara">All statistical analyses were performed using SPSS software&#44; version 11&#46;5&#46;</p><p class="elsevierStylePara">We used the Kolmogorov-Smirnov test to evaluate whether the study variables adhered to a normal distribution&#46; For two-sample parametric variables&#44; we used paired Student&#8217;s t-tests&#44; and ANOVA tests for cases of more than two comparisons&#46; For two-sample variables that did not adhere to a normal distribution&#44; we used the Wilcoxon non-parametric test for paired samples&#44; and repeated measures tests for cases of more than two comparisons&#46; We also used &#935;<span class="elsevierStyleSup">2</span>&#160;and Fisher&#8217;s exact tests to compare proportions between categorical variables&#46; We evaluated bivariate relationships using a linear regression analysis&#44; and calculated Pearson&#8217;s correlation coefficients in order to evaluate goodness of fit&#46;</p><p class="elsevierStylePara">We considered a <span class="elsevierStyleItalic">P</span>-value &#60;&#46;05 to be statistically significant&#46;</p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Ethical considerations</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">This study was carried out in accordance with the recommendations of the Helsinki Declaration of 1964&#44; for the orientation of performing biomedical research in human subjects&#46;</p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">&#160;</span><span class="elsevierStyleBold">RESULTS</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">The demographic characteristics of the patients included in our study are described in Table 1&#46;</p><p class="elsevierStylePara">We used systemic anticoagulation therapy only during sessions involving a conventional dialyser&#46; The mean dose of nadroparin was 2500&#177;547&#46;7IU &#40;38&#46;5&#177;8&#46;2IU&#47;kg&#41;&#46;</p><p class="elsevierStylePara">In our study&#44; we did not observe differences in the distribution of coagulation levels between the two types of dialysers&#46; No cases of complete or level 4 coagulation &#40;&#62;50&#37; of the fibres in the dialyser coagulated&#41; were observed in any of the 36 sessions using a conventional dialyser or the 36 sessions involving the AN69ST<span class="elsevierStyleSup">&#174;</span> system&#46; Partial coagulation less than 25&#37; &#40;level 1-2&#41; was observed in 32 &#40;88&#46;9&#37;&#41; of sessions using the AN69ST<span class="elsevierStyleSup">&#174;</span> system&#44; and 35 &#40;97&#44;2&#37;&#41; sessions using the conventional dialyser&#44; and greater than 25&#37; &#40;level 3&#41; in 4 &#40;11&#46;1&#37;&#41; sessions without heparin and 1 &#40;2&#46;8&#37;&#41; session with the dialyser using heparin &#40;Table 2&#41;&#46;</p><p class="elsevierStylePara">Coagulation in the arterial bubble trap did not surpass 25&#37; &#40;levels 3 and 4&#41; in any of the dialysis sessions&#44; and this value was surpassed in the venous chamber in only one &#40;2&#46;8&#37;&#41; session using the conventional dialyser and in three &#40;8&#46;4&#37;&#41; sessions using the AN69ST<span class="elsevierStyleSup">&#174;</span>&#46; There were no significant differences between the two dialysers&#46;</p><p class="elsevierStylePara">The APTT value after two hours was significantly different between the two techniques&#44; and was correlated with the administration of LMWH &#40;33&#46;3&#177;2&#46;7s with polysulfone and 27&#46;5&#177;2&#46;3s with AN69ST<span class="elsevierStyleSup">&#174;</span>&#59; <span class="elsevierStyleItalic">P</span>&#60;&#46;05&#41;&#44; and these differences continued to be significant at the end of the session &#40;29&#46;8&#177;2&#46;1s with polysulfone and 27&#46;2&#177;1&#46;8s with AN69ST<span class="elsevierStyleSup">&#174;</span>&#59; <span class="elsevierStyleItalic">P</span>&#60;&#46;05&#41; &#40;Table 3&#41;&#46;</p><p class="elsevierStylePara">The anti-Xa factor value reached a maximum two hours after administering LMWH&#44; with statistically significant differences between the two dialysers &#40;0&#46;46&#177;0&#46;13IU&#47;ml in dialysis with nadroparin and 0&#46;04&#177;0&#46;04IU&#47;ml in AN69ST<span class="elsevierStyleSup">&#174;</span>&#59; <span class="elsevierStyleItalic">P</span>&#60;&#46;005&#41;&#44; and then decreased after 4 hours &#40;0&#46;17&#177;0&#46;12IU&#47;ml in dialysis with nadroparin and 0&#46;02&#177;0&#46;03IU&#47;ml in AN69ST<span class="elsevierStyleSup">&#174;</span>&#59; <span class="elsevierStyleItalic">P</span>&#60;&#46;05&#41; for both modalities&#46; A positive relationship was established between APTT and anti-Xa factor &#40;regression equation&#58; y&#61;27&#46;9&#43;7&#46;58x&#59; r&#61;0&#46;44&#41; &#40;Figure&#41;&#46;</p><p class="elsevierStylePara">The mean Kt&#47;V value was similar for the two different treatments&#46;</p><p class="elsevierStylePara">One patient on the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser developed abrupt hypotension with loss of consciousness&#46; One patient on the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser was excluded from the study due to an adverse reaction in the form of generalised pruritus&#44; for which the patient retracted the informed consent after the first session&#46; Another patient developed nausea and general discomfort 15 minutes after starting a session using the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser&#44; which was resolved with metoclopramide&#44; and no further incidents occurred&#46;</p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">DISCUSSION</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">The type of dialyser and form of HD used are determining factors in the parameters of thrombogenicity present during dialysis sessions&#46; The dialyser provides the largest surface area exposed to the blood&#46; Flow control and circuit pressures are other factors that can be modified to minimise the activation of the coagulation pathway&#46; In our study&#44; we demonstrated a low thrombogenicity of the polyacrylonitrile AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;dialyser&#44; without needing anticoagulation therapy&#46; The results were similar to those observed using a conventional high-permeability polysulfone dialyser with anticoagulation therapy in the form of LMWH using post-dilution HDF&#46; This modality favours haemoconcentration throughout the dialyser capillaries&#44; since the replacement infusion volume comes after ultrafiltration&#46; These results are possible due to the presence of polyethylenimine as the polymer that covers and neutralises the negative charge of the polyacrylonitrile&#44; allowing for the binding of unfractionated heparin molecules&#46; The modifications made to the surface&#44; along with the heparin coating&#44; increase the biocompatibility of the dialyser membrane&#46;<span class="elsevierStyleSup">13-15</span> This membrane pre-treatment minimises the binding of molecules involved in the contact activation of the intrinsic coagulation pathway&#46;</p><p class="elsevierStylePara">Neither the dialyser nor the rest of the extracorporeal circuit were completely coagulated in any of the 36 sessions performed using the conventional dialyser or the AN69ST<span class="elsevierStyleSup">&#174;</span>&#46; These findings are in accordance with previously published results&#44; which situate the rate of complete system coagulation at 0&#46;5&#37;-2&#37; of sessions&#46;<span class="elsevierStyleSup">9&#44;16</span> In sheep models&#44; HD sessions were administered using the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser with heparin coating and without systemic anticoagulation therapy&#44; with no system coagulation produced during 6-hour sessions&#46; Under these same conditions&#44; massive circuit coagulation was produced after 90 minutes using the AN69<span class="elsevierStyleSup">&#174;</span> dialyser without heparin coating&#46;<span class="elsevierStyleSup">10</span> Studies in humans using the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser require an optimum level of sodium heparin &#40;2000-3000IU&#41;&#44; administered intermittently&#59; with this prescription&#44; partial coagulation was observed in 5&#47;39 sessions using 2000IU heparin and 2&#47;150 sessions with 3000IU heparin &#40;<span class="elsevierStyleItalic">P</span>&#60;&#46;008&#41;&#46; As regards the need for LMWH&#44; 20mg of enoxaparin were administered&#44; and no episodes of system coagulation were observed in the 30 sessions administered&#46; When the dose was reduced to 10mg&#44; partial coagulation was produced in 7&#47;29 sessions&#46;<span class="elsevierStyleSup">10</span></p><p class="elsevierStylePara">The experience gained using the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser without heparin and with adequate supervision resulted in only 1 case of massive system coagulation and 17 cases of partial or &#62;25&#37; coagulation in a sample of 66 sessions&#46;<span class="elsevierStyleSup">10</span> Prior to the dialysis sessions&#44; both groups were primed with a heparinised solution&#44; such that the heparin would impregnate the membrane surface and maintain its anticoagulant effects during the session&#44; without requiring systemic heparin administration&#46; In a randomised crossed sample of 54 patients on HD without heparin&#44; 6&#37; of sessions were interrupted due to complete coagulation of the dialysers&#46; A total of 9&#37; of the sessions were with AN69ST<span class="elsevierStyleSup">&#174;</span>&#44; and 13&#37; with polysulfone developed partial circuit coagulation&#44; with a persistent increase in venous pressure&#46;<span class="elsevierStyleSup">11</span> Upon comparing the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser with another polysulfone dialyser using a visual scale&#44; in patients in which the anticoagulation therapy had been decreased by 50&#37;&#44; no differences were observed in coagulation in the venous bubble trap&#46;<span class="elsevierStyleSup">15</span></p><p class="elsevierStylePara">Anticoagulation therapy in HD implies a risk for active bleeding in dialysis patients&#44; both as a new condition and in terms of worsening pre-existing issues&#46; Standard systemic heparinisation has been associated with a risk of haemorrhagic complications that can occur in as many as 26&#37; of all sessions&#46;<span class="elsevierStyleSup">17</span> Several different alternatives have been used in patients with a high risk of bleeding&#46; Intermittent flushes with saline solution do not appear to improve the visual signs of circuit coagulation or intravascular coagulating activity parameters in stable patients&#46;<span class="elsevierStyleSup">18</span> It is used in 90&#37; of patients in intensive care units&#44; with only 2&#37; of cases developing complete circuit coagulation&#46;<span class="elsevierStyleSup">16</span> Regional heparinisation or small controlled doses of heparin have been used in different studies involving patients with a high risk of bleeding&#46;<span class="elsevierStyleSup">19</span> Using the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser allows for reducing the dose of unfractionated heparin administered in HD by 50&#37;&#44; without increasing the risk of circuit coagulation&#46;<span class="elsevierStyleSup">7</span></p><p class="elsevierStylePara">In our study&#44; we observed a positive relationship between APTT and anti-Xa factor levels&#46; Both values increased two hours after starting heparin administration&#46; Anti-Xa values remained stable during the entire session with the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser&#44; whereas in sessions with systemic heparinisation&#44; these levels increased&#44; reaching values that avoid circuit coagulation but that alter the coagulation state of the patient&#46; In the last two hours&#44; levels decreased&#44; but remained above normal at the end of the HD session&#46; Specific haemostasis values have been defined that reduce the risk of circuit coagulation&#46; APTT must be maintained &#62;40s and anti-Xa factor &#62;0&#46;2mIU&#47;ml&#44; based on the results from visual inspection of the dialyser and chambers&#46;<span class="elsevierStyleSup">10 </span>In sessions with nadroparin&#44; despite using doses of 38&#46;5&#177;8&#46;2IU&#47;kg&#44; anti-Xa levels remained close to 0&#46;2 at the end of the HD session&#44; which implies a risk of haemorrhage that is not reflected in the value of APTT&#44; which decreased to levels similar to those at the start of the session&#46;</p><p class="elsevierStylePara">Other studies using the AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;have encountered various factors that serve as measures of thrombogenicity during the HD session&#44; such as prothrombin fragment 1&#43;2 as a marker for the vascular formation of thrombin&#44; thrombin-antithrombin III complexes&#44; or B-thromboglobulin as a marker for platelet activation&#46;<span class="elsevierStyleSup">18</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">CONCLUSIONS</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">In our study&#44; we demonstrated a low thrombogenicity of the AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;dialyser&#44; such that we were able to perform sessions of post-dilution HDF without requiring systemic anticoagulation&#44; without increasing the frequency of severe coagulation events&#44; and with a lower risk of bleeding by not modifying the anti-Xa factor&#46;</p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Conflicts of interest</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">The authors have no conflicts of interest to declare&#46;</p><p class="elsevierStylePara"><a href="grande&#47;11486&#95;16025&#95;35194&#95;en&#95;t1&#95;11486&#95;i&#46;jpg" class="elsevierStyleCrossRefs"><img src="11486_16025_35194_en_t1_11486_i.jpg" alt="Demographic characteristics of the study population "></img></a></p><p class="elsevierStylePara">Table 1&#46; Demographic characteristics of the study population </p><p class="elsevierStylePara"><a href="grande&#47;11486&#95;16025&#95;35195&#95;en&#95;t2&#95;11486&#95;i&#46;jpg" class="elsevierStyleCrossRefs"><img src="11486_16025_35195_en_t2_11486_i.jpg" alt="Technical characteristics of dialysis sessions "></img></a></p><p class="elsevierStylePara">Table 2&#46; Technical characteristics of dialysis sessions </p><p class="elsevierStylePara"><a href="grande&#47;11486&#95;16025&#95;35196&#95;en&#95;t3&#95;11486&#95;i&#46;jpg" class="elsevierStyleCrossRefs"><img src="11486_16025_35196_en_t3_11486_i.jpg" alt="Patient results &#40;coagulation and dialysis efficacy parameters&#41; "></img></a></p><p class="elsevierStylePara">Table 3&#46; Patient results &#40;coagulation and dialysis efficacy parameters&#41; </p><p class="elsevierStylePara"><a href="grande&#47;11486&#95;16025&#95;35197&#95;en&#95;f1&#95;11486&#95;i&#46;jpg" class="elsevierStyleCrossRefs"><img src="11486_16025_35197_en_f1_11486_i.jpg" alt="Association between APTT and anti-Xa factor during the 4 hours of treatment "></img></a></p><p class="elsevierStylePara">Figure 1&#46; Association between APTT and anti-Xa factor during the 4 hours of treatment </p>"
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        "resumen" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">Introducci&#243;n&#58;</span> Los sistemas de hemodi&#225;lisis tienen capacidad trombog&#233;nica&#44; por lo que se utiliza de forma rutinaria la anticoagulaci&#243;n&#46; Su prescripci&#243;n no se encuentra exenta de riesgos&#44; a pesar de lo cual las recomendaciones respecto a la dosis pautada siguen bas&#225;ndose en criterios muy diversos&#46; <span class="elsevierStyleBold">M&#233;todos&#58;</span> Se realiz&#243; un estudio experimental aleatorizado y cruzado&#46; Seis pacientes realizaron seis sesiones de hemodiafiltraci&#243;n posdiluci&#243;n con el dializador de polisulfona HF80<span class="elsevierStyleSup">&#174;</span> y anticoagulaci&#243;n habitual con nadroparina&#44; y seis sesiones con el dializador AN69ST<span class="elsevierStyleSup">&#174;</span> de poliacrilonitrilo con una cubierta de heparina sin el uso de anticoagulaci&#243;n sist&#233;mica&#46; Evaluamos cada hora el grado de coagulaci&#243;n del dializador y del circuito extracorp&#243;reo mediante una escala visual y las variaciones en los par&#225;metros de coagulaci&#243;n&#44; entre los que se incluy&#243; el factor anti-Xa&#46; Nuestro objetivo primario fue valorar las variaciones en la actividad del factor anti-Xa en ausencia de diferencias en la tasa de coagulaci&#243;n masiva entre los dos grupos&#46; <span class="elsevierStyleBold">Resultados&#58;</span> No se coagul&#243; el dializador de forma completa o grado 4 en ninguna de las 36 sesiones realizadas con cada dializador&#46; Se produjo una coagulaci&#243;n parcial del dializador inferior del 25&#37; &#40;grado 1-2&#41; en 32 &#40;88&#44;9&#37;&#41; sesiones con AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;y 35 &#40;97&#44;2&#37;&#41; con el dializador habitual&#44; y superior del 25&#37; &#40;grado 3-4&#41; en 4 &#40;11&#44;1&#37;&#41; sesiones con AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;y en 1 &#40;2&#44;8&#37;&#41; sesi&#243;n con el dializador con heparina&#46; La coagulaci&#243;n del atrapaburbujas arterial no fue superior al 25&#37; &#40;grados 3 y 4&#41; en ninguna de las sesiones estudiadas&#44; y la c&#225;mara venosa en s&#243;lo 1 &#40;2&#44;8&#37;&#41; sesi&#243;n con el dializador habitual y 3 &#40;8&#44;4&#37;&#41; con AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;sin diferencias entre los dos dializadores&#46; El valor del tiempo de tromboplastina parcial activada present&#243; diferencias a las dos horas entre ambas t&#233;cnicas&#44; relacionadas con la administraci&#243;n de la heparina de bajo peso molecular &#40;33&#44;3 &#177; 2&#44;7 s con polisulfona y 27&#44;5 &#177; 2&#44;3 s en AN69ST<span class="elsevierStyleSup">&#174;</span>&#44; p &#60; 0&#44;05&#41;&#44; que continuaron siendo significativas al finalizar la sesi&#243;n &#40;29&#44;8 &#177; 2&#44;1 s con polisulfona y 27&#44;2 &#177; 1&#44;8 s con AN69ST<span class="elsevierStyleSup">&#174;</span>&#44; p &#60; 0&#44;05&#41;&#46; La actividad del factor anti-Xa fue m&#225;xima dos horas despu&#233;s de la administraci&#243;n de nadroparina&#44; con diferencias entre ambos dializadores &#40;0&#44;46 &#177; 0&#44;13 UI&#47;ml en di&#225;lisis con polisulfona y 0&#44;04 &#177; 0&#44;04 UI&#47;ml con AN69ST<span class="elsevierStyleSup">&#174;</span>&#44; p &#60; 0&#44;005&#41;&#44; para ir descendiendo en la determinaci&#243;n de las 4 horas &#40;0&#44;17 &#177; 0&#44;12 UI&#47;ml en di&#225;lisis con polisulfona y 0&#44;02 &#177; 0&#44;03 UI&#47;ml en AN69ST<span class="elsevierStyleSup">&#174;</span>&#44; p &#60; 0&#44;05&#41;&#46; Un paciente fue excluido del estudio al presentar una reacci&#243;n adversa caracterizada por prurito generalizado con el dializador AN69ST<span class="elsevierStyleSup">&#174;</span>&#44; motivo por el que retir&#243; en la primera sesi&#243;n el consentimiento&#46; <span class="elsevierStyleBold">Conclusi&#243;n&#58;</span> Demostramos la baja trombogenicidad del dializador AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;de forma que permite realizar sesiones de hemodiafiltraci&#243;n posdiluci&#243;n sin necesidad de anticoagulaci&#243;n sist&#233;mica&#44; y sin aumentar la frecuencia de eventos de coagulaci&#243;n grave en comparaci&#243;n con el dializador HF80<span class="elsevierStyleSup">&#174;</span>&#160;junto a nadroparina y con menor riesgo de sangrado al no modificar la actividad del factor anti-Xa&#46;</p>"
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Evaluation of coagulation and anti-Xa factor when using a heparin-coated AN69ST® dialyser
Valoración del grado de coagulación y del factor anti-Xa al introducir el dializador AN69ST® con heparina impregnada
Juan José Sánchez Canela, Juan J. Sánchez-Canelb, Ramón Pons Pradesa, Ramón Pons-Pradesb, María Laura Salvettia, M. Laura Salvettib, Alejandro Seoresb, Milagros Vázquezb, Alejandro Pérez Albaa, Alejandro Pérez-Albab, Esther Tamaritb, Consuelo Calvo Gordoa, Consuelo Calvo-Gordob, Juan Villatorob
a Unidad de Nefrología, Hospital General de Castellón Castellón, Castellón, Spain,
b Unidad de Nefrología, Hospital General de Castellón, Castellón,
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unfractionated sodium heparin has been used for this purpose&#46; The anti-coagulation properties of this compound are based on the conformational change of antithrombin III and the inactivation of coagulation factors&#44; above all Xa&#46; The effects of administering sodium heparin are immediate&#44; with a half-life of 30 minutes to 2 hours&#46; It is generally administered in boluses&#44; a continuous drip&#44; or through regional heparinisation&#44; and is associated with secondary side effects such as haemorrhage due to excess doses&#44; thrombocytopenia mediated by IgG-heparin immunocomplexes&#44; and thrombocytopenia-associated thrombosis&#46; Other undesirable effects that can appear include hypersensitivity&#44; cutaneous necrosis&#44; and osteoporosis&#46;<span class="elsevierStyleSup">2</span></p><p class="elsevierStylePara">Low-molecular weight heparin &#40;LMWH&#41; provides an alternative for anticoagulation therapy&#46; This drug is obtained by degrading the original heparin molecule into fractions of 4-6kDa&#46; LMWH is used for its lower associated risk of bleeding&#44; since it does not produce an anti-thrombin response&#46; However&#44; it does inhibit Xa&#44; XIIa&#44; and kallikrein&#44; without producing any effect on thrombin&#44; IX&#44; or XI&#46; The half-life of LMWH is longer than normal heparin&#44; which allows for a single dose administered at the start of dialysis that is expressed in anti-Xa units&#46; Although this drug is more expensive&#44; it has fewer secondary side effects on platelet aggregation and thus produces fewer issues with bleeding&#46; The European Best Practice guidelines recommend LMWH as the anticoagulant of choice for dialysis&#46;<span class="elsevierStyleSup">3</span></p><p class="elsevierStylePara">Several different factors can increase the tendency of the circuit for coagulation&#44; such as low blood flow&#44; elevated haematocrit&#44; and high rate of ultrafiltration&#59; in addition&#44; technical errors are an important cause of system coagulations&#46; 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Every hour&#44; 100ml of saline solution was infused in order to observe the coagulation level of the dialyser and bubble trap&#46;</p><p class="elsevierStylePara">On the sixth session&#44; in each of the periods&#44; we determined haemogram values in order to evaluate platelet count and haemostasis&#58; prothrombin time&#44; Quick index&#44; APTT&#44; and fibrinogen&#44; and we also measured anti-Xa factor levels&#46; The laboratory analyses were collected at the start of HD&#44; after 2 hours&#44; after ending the session&#44; and prior to the following dialysis session or 44 hours later&#46; We also measured plasma concentrations of urea&#44; creatinine&#44; glucose&#44; sodium&#44; potassium&#44; calcium&#44; phosphorous&#44; total protein&#44; albumin&#44; uric acid&#44; and C-reactive protein at the start of HD and at the end of each session&#46;</p><p class="elsevierStylePara">The dosage for dialysis sessions was measured using the following formulas&#58;</p><p class="elsevierStylePara">&#160;</p><ul><li>Kt&#47;V second generation Daugirdas&#58; Kt&#47;V&#61; &#8211;Ln &#40;&#91;C2&#47;C1&#93; &#8211; &#91;0&#46;008&#42;T&#93;&#41; &#43; &#40;4 &#8211; 3&#46;5 &#42; &#91;C2&#47;C1&#93;&#41; &#42; UF&#47;final weight&#46;</li><li>Kt&#47;V corrected for rebound&#58; Kt&#47;Vr &#61; Kt&#47;V &#42; &#40;1 &#8211;&#160;&#91;0&#46;6&#47;T&#93;&#41; &#43; 0&#46;03</li></ul><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">Samples were sent for processing to the haematology laboratory at the Castellon General Hospital&#46;</p><p class="elsevierStylePara">Samples were extracted for laboratory analyses after each session from 20-25ml of blood taken from the arterial branch after slowing the arterial pump to a flow of 50ml&#47;min during one minute&#44; according to the standard department protocols&#46;</p><p class="elsevierStylePara">We evaluated circuit coagulation every hour using a photographic visual scale with 4 different coagulation levels in the arterial and venous bubble traps&#58;</p><p class="elsevierStylePara">&#160;</p><ul><li>1 &#61; normal&#46;</li><li>2 &#61; fibrous ring&#46;</li><li>3 &#61; clot formation&#46;</li><li>4 &#61; system coagulated&#46;</li></ul><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">The dialyser was inspected every hour until the end of each the dialysis session&#58;</p><p class="elsevierStylePara">&#160;</p><ul><li>1 &#61; normal&#46;</li><li>2 &#61; less than 25&#37; of capillaries coagulated&#46;</li><li>3 &#61; 25-50&#37; of capillaries coagulated&#46;</li><li>4 &#61; dialyser completely coagulated&#46;</li></ul><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Statistical analysis</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">Prior to the study&#44; we calculated the optimal sample size in order to achieve a statistical power of 80&#37; and a 95&#37; confidence interval for paired samples&#46; The sample size was calculated by comparing the two means for anti-Xa factor obtained in studies from the medical literature&#46;<span class="elsevierStyleSup">6&#44;10</span> We also estimated the standard deviation of the mean at 0&#46;1&#44; based on previous studies&#46; We defined Epsilon&#44; which is the minimal difference between means that is considered of practical importance&#44; at 0&#46;2&#46; We estimated that 4 patients would be needed&#44; and taking into account the possible loss of 15&#37; of the study sample&#44; 2 more patients were added&#46;</p><p class="elsevierStylePara">The risk of moderate or severe coagulation events with systemic heparinisation was defined as 5&#37; of sessions&#44; with a noninferiority margin of 10&#37;&#46;<span class="elsevierStyleSup">6&#44;11&#44;12 </span>The unilateral &#945; risk was 0&#46;95&#46; The number of sessions required &#40;result&#41; was 58&#46; The possible loss of patients was estimated at 15&#37;&#46;</p><p class="elsevierStylePara">All statistical analyses were performed using SPSS software&#44; version 11&#46;5&#46;</p><p class="elsevierStylePara">We used the Kolmogorov-Smirnov test to evaluate whether the study variables adhered to a normal distribution&#46; For two-sample parametric variables&#44; we used paired Student&#8217;s t-tests&#44; and ANOVA tests for cases of more than two comparisons&#46; For two-sample variables that did not adhere to a normal distribution&#44; we used the Wilcoxon non-parametric test for paired samples&#44; and repeated measures tests for cases of more than two comparisons&#46; We also used &#935;<span class="elsevierStyleSup">2</span>&#160;and Fisher&#8217;s exact tests to compare proportions between categorical variables&#46; We evaluated bivariate relationships using a linear regression analysis&#44; and calculated Pearson&#8217;s correlation coefficients in order to evaluate goodness of fit&#46;</p><p class="elsevierStylePara">We considered a <span class="elsevierStyleItalic">P</span>-value &#60;&#46;05 to be statistically significant&#46;</p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Ethical considerations</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">This study was carried out in accordance with the recommendations of the Helsinki Declaration of 1964&#44; for the orientation of performing biomedical research in human subjects&#46;</p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">&#160;</span><span class="elsevierStyleBold">RESULTS</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">The demographic characteristics of the patients included in our study are described in Table 1&#46;</p><p class="elsevierStylePara">We used systemic anticoagulation therapy only during sessions involving a conventional dialyser&#46; The mean dose of nadroparin was 2500&#177;547&#46;7IU &#40;38&#46;5&#177;8&#46;2IU&#47;kg&#41;&#46;</p><p class="elsevierStylePara">In our study&#44; we did not observe differences in the distribution of coagulation levels between the two types of dialysers&#46; No cases of complete or level 4 coagulation &#40;&#62;50&#37; of the fibres in the dialyser coagulated&#41; were observed in any of the 36 sessions using a conventional dialyser or the 36 sessions involving the AN69ST<span class="elsevierStyleSup">&#174;</span> system&#46; Partial coagulation less than 25&#37; &#40;level 1-2&#41; was observed in 32 &#40;88&#46;9&#37;&#41; of sessions using the AN69ST<span class="elsevierStyleSup">&#174;</span> system&#44; and 35 &#40;97&#44;2&#37;&#41; sessions using the conventional dialyser&#44; and greater than 25&#37; &#40;level 3&#41; in 4 &#40;11&#46;1&#37;&#41; sessions without heparin and 1 &#40;2&#46;8&#37;&#41; session with the dialyser using heparin &#40;Table 2&#41;&#46;</p><p class="elsevierStylePara">Coagulation in the arterial bubble trap did not surpass 25&#37; &#40;levels 3 and 4&#41; in any of the dialysis sessions&#44; and this value was surpassed in the venous chamber in only one &#40;2&#46;8&#37;&#41; session using the conventional dialyser and in three &#40;8&#46;4&#37;&#41; sessions using the AN69ST<span class="elsevierStyleSup">&#174;</span>&#46; There were no significant differences between the two dialysers&#46;</p><p class="elsevierStylePara">The APTT value after two hours was significantly different between the two techniques&#44; and was correlated with the administration of LMWH &#40;33&#46;3&#177;2&#46;7s with polysulfone and 27&#46;5&#177;2&#46;3s with AN69ST<span class="elsevierStyleSup">&#174;</span>&#59; <span class="elsevierStyleItalic">P</span>&#60;&#46;05&#41;&#44; and these differences continued to be significant at the end of the session &#40;29&#46;8&#177;2&#46;1s with polysulfone and 27&#46;2&#177;1&#46;8s with AN69ST<span class="elsevierStyleSup">&#174;</span>&#59; <span class="elsevierStyleItalic">P</span>&#60;&#46;05&#41; &#40;Table 3&#41;&#46;</p><p class="elsevierStylePara">The anti-Xa factor value reached a maximum two hours after administering LMWH&#44; with statistically significant differences between the two dialysers &#40;0&#46;46&#177;0&#46;13IU&#47;ml in dialysis with nadroparin and 0&#46;04&#177;0&#46;04IU&#47;ml in AN69ST<span class="elsevierStyleSup">&#174;</span>&#59; <span class="elsevierStyleItalic">P</span>&#60;&#46;005&#41;&#44; and then decreased after 4 hours &#40;0&#46;17&#177;0&#46;12IU&#47;ml in dialysis with nadroparin and 0&#46;02&#177;0&#46;03IU&#47;ml in AN69ST<span class="elsevierStyleSup">&#174;</span>&#59; <span class="elsevierStyleItalic">P</span>&#60;&#46;05&#41; for both modalities&#46; A positive relationship was established between APTT and anti-Xa factor &#40;regression equation&#58; y&#61;27&#46;9&#43;7&#46;58x&#59; r&#61;0&#46;44&#41; &#40;Figure&#41;&#46;</p><p class="elsevierStylePara">The mean Kt&#47;V value was similar for the two different treatments&#46;</p><p class="elsevierStylePara">One patient on the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser developed abrupt hypotension with loss of consciousness&#46; One patient on the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser was excluded from the study due to an adverse reaction in the form of generalised pruritus&#44; for which the patient retracted the informed consent after the first session&#46; Another patient developed nausea and general discomfort 15 minutes after starting a session using the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser&#44; which was resolved with metoclopramide&#44; and no further incidents occurred&#46;</p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">DISCUSSION</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">The type of dialyser and form of HD used are determining factors in the parameters of thrombogenicity present during dialysis sessions&#46; The dialyser provides the largest surface area exposed to the blood&#46; Flow control and circuit pressures are other factors that can be modified to minimise the activation of the coagulation pathway&#46; In our study&#44; we demonstrated a low thrombogenicity of the polyacrylonitrile AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;dialyser&#44; without needing anticoagulation therapy&#46; The results were similar to those observed using a conventional high-permeability polysulfone dialyser with anticoagulation therapy in the form of LMWH using post-dilution HDF&#46; This modality favours haemoconcentration throughout the dialyser capillaries&#44; since the replacement infusion volume comes after ultrafiltration&#46; These results are possible due to the presence of polyethylenimine as the polymer that covers and neutralises the negative charge of the polyacrylonitrile&#44; allowing for the binding of unfractionated heparin molecules&#46; The modifications made to the surface&#44; along with the heparin coating&#44; increase the biocompatibility of the dialyser membrane&#46;<span class="elsevierStyleSup">13-15</span> This membrane pre-treatment minimises the binding of molecules involved in the contact activation of the intrinsic coagulation pathway&#46;</p><p class="elsevierStylePara">Neither the dialyser nor the rest of the extracorporeal circuit were completely coagulated in any of the 36 sessions performed using the conventional dialyser or the AN69ST<span class="elsevierStyleSup">&#174;</span>&#46; These findings are in accordance with previously published results&#44; which situate the rate of complete system coagulation at 0&#46;5&#37;-2&#37; of sessions&#46;<span class="elsevierStyleSup">9&#44;16</span> In sheep models&#44; HD sessions were administered using the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser with heparin coating and without systemic anticoagulation therapy&#44; with no system coagulation produced during 6-hour sessions&#46; Under these same conditions&#44; massive circuit coagulation was produced after 90 minutes using the AN69<span class="elsevierStyleSup">&#174;</span> dialyser without heparin coating&#46;<span class="elsevierStyleSup">10</span> Studies in humans using the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser require an optimum level of sodium heparin &#40;2000-3000IU&#41;&#44; administered intermittently&#59; with this prescription&#44; partial coagulation was observed in 5&#47;39 sessions using 2000IU heparin and 2&#47;150 sessions with 3000IU heparin &#40;<span class="elsevierStyleItalic">P</span>&#60;&#46;008&#41;&#46; As regards the need for LMWH&#44; 20mg of enoxaparin were administered&#44; and no episodes of system coagulation were observed in the 30 sessions administered&#46; When the dose was reduced to 10mg&#44; partial coagulation was produced in 7&#47;29 sessions&#46;<span class="elsevierStyleSup">10</span></p><p class="elsevierStylePara">The experience gained using the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser without heparin and with adequate supervision resulted in only 1 case of massive system coagulation and 17 cases of partial or &#62;25&#37; coagulation in a sample of 66 sessions&#46;<span class="elsevierStyleSup">10</span> Prior to the dialysis sessions&#44; both groups were primed with a heparinised solution&#44; such that the heparin would impregnate the membrane surface and maintain its anticoagulant effects during the session&#44; without requiring systemic heparin administration&#46; In a randomised crossed sample of 54 patients on HD without heparin&#44; 6&#37; of sessions were interrupted due to complete coagulation of the dialysers&#46; A total of 9&#37; of the sessions were with AN69ST<span class="elsevierStyleSup">&#174;</span>&#44; and 13&#37; with polysulfone developed partial circuit coagulation&#44; with a persistent increase in venous pressure&#46;<span class="elsevierStyleSup">11</span> Upon comparing the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser with another polysulfone dialyser using a visual scale&#44; in patients in which the anticoagulation therapy had been decreased by 50&#37;&#44; no differences were observed in coagulation in the venous bubble trap&#46;<span class="elsevierStyleSup">15</span></p><p class="elsevierStylePara">Anticoagulation therapy in HD implies a risk for active bleeding in dialysis patients&#44; both as a new condition and in terms of worsening pre-existing issues&#46; Standard systemic heparinisation has been associated with a risk of haemorrhagic complications that can occur in as many as 26&#37; of all sessions&#46;<span class="elsevierStyleSup">17</span> Several different alternatives have been used in patients with a high risk of bleeding&#46; Intermittent flushes with saline solution do not appear to improve the visual signs of circuit coagulation or intravascular coagulating activity parameters in stable patients&#46;<span class="elsevierStyleSup">18</span> It is used in 90&#37; of patients in intensive care units&#44; with only 2&#37; of cases developing complete circuit coagulation&#46;<span class="elsevierStyleSup">16</span> Regional heparinisation or small controlled doses of heparin have been used in different studies involving patients with a high risk of bleeding&#46;<span class="elsevierStyleSup">19</span> Using the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser allows for reducing the dose of unfractionated heparin administered in HD by 50&#37;&#44; without increasing the risk of circuit coagulation&#46;<span class="elsevierStyleSup">7</span></p><p class="elsevierStylePara">In our study&#44; we observed a positive relationship between APTT and anti-Xa factor levels&#46; Both values increased two hours after starting heparin administration&#46; Anti-Xa values remained stable during the entire session with the AN69ST<span class="elsevierStyleSup">&#174;</span> dialyser&#44; whereas in sessions with systemic heparinisation&#44; these levels increased&#44; reaching values that avoid circuit coagulation but that alter the coagulation state of the patient&#46; In the last two hours&#44; levels decreased&#44; but remained above normal at the end of the HD session&#46; Specific haemostasis values have been defined that reduce the risk of circuit coagulation&#46; APTT must be maintained &#62;40s and anti-Xa factor &#62;0&#46;2mIU&#47;ml&#44; based on the results from visual inspection of the dialyser and chambers&#46;<span class="elsevierStyleSup">10 </span>In sessions with nadroparin&#44; despite using doses of 38&#46;5&#177;8&#46;2IU&#47;kg&#44; anti-Xa levels remained close to 0&#46;2 at the end of the HD session&#44; which implies a risk of haemorrhage that is not reflected in the value of APTT&#44; which decreased to levels similar to those at the start of the session&#46;</p><p class="elsevierStylePara">Other studies using the AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;have encountered various factors that serve as measures of thrombogenicity during the HD session&#44; such as prothrombin fragment 1&#43;2 as a marker for the vascular formation of thrombin&#44; thrombin-antithrombin III complexes&#44; or B-thromboglobulin as a marker for platelet activation&#46;<span class="elsevierStyleSup">18</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">CONCLUSIONS</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">In our study&#44; we demonstrated a low thrombogenicity of the AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;dialyser&#44; such that we were able to perform sessions of post-dilution HDF without requiring systemic anticoagulation&#44; without increasing the frequency of severe coagulation events&#44; and with a lower risk of bleeding by not modifying the anti-Xa factor&#46;</p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Conflicts of interest</span></p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara">The authors have no conflicts of interest to declare&#46;</p><p class="elsevierStylePara"><a href="grande&#47;11486&#95;16025&#95;35194&#95;en&#95;t1&#95;11486&#95;i&#46;jpg" class="elsevierStyleCrossRefs"><img src="11486_16025_35194_en_t1_11486_i.jpg" alt="Demographic characteristics of the study population "></img></a></p><p class="elsevierStylePara">Table 1&#46; Demographic characteristics of the study population </p><p class="elsevierStylePara"><a href="grande&#47;11486&#95;16025&#95;35195&#95;en&#95;t2&#95;11486&#95;i&#46;jpg" class="elsevierStyleCrossRefs"><img src="11486_16025_35195_en_t2_11486_i.jpg" alt="Technical characteristics of dialysis sessions "></img></a></p><p class="elsevierStylePara">Table 2&#46; Technical characteristics of dialysis sessions </p><p class="elsevierStylePara"><a href="grande&#47;11486&#95;16025&#95;35196&#95;en&#95;t3&#95;11486&#95;i&#46;jpg" class="elsevierStyleCrossRefs"><img src="11486_16025_35196_en_t3_11486_i.jpg" alt="Patient results &#40;coagulation and dialysis efficacy parameters&#41; "></img></a></p><p class="elsevierStylePara">Table 3&#46; Patient results &#40;coagulation and dialysis efficacy parameters&#41; </p><p class="elsevierStylePara"><a href="grande&#47;11486&#95;16025&#95;35197&#95;en&#95;f1&#95;11486&#95;i&#46;jpg" class="elsevierStyleCrossRefs"><img src="11486_16025_35197_en_f1_11486_i.jpg" alt="Association between APTT and anti-Xa factor during the 4 hours of treatment "></img></a></p><p class="elsevierStylePara">Figure 1&#46; Association between APTT and anti-Xa factor during the 4 hours of treatment </p>"
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        "resumen" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">Introducci&#243;n&#58;</span> Los sistemas de hemodi&#225;lisis tienen capacidad trombog&#233;nica&#44; por lo que se utiliza de forma rutinaria la anticoagulaci&#243;n&#46; Su prescripci&#243;n no se encuentra exenta de riesgos&#44; a pesar de lo cual las recomendaciones respecto a la dosis pautada siguen bas&#225;ndose en criterios muy diversos&#46; <span class="elsevierStyleBold">M&#233;todos&#58;</span> Se realiz&#243; un estudio experimental aleatorizado y cruzado&#46; Seis pacientes realizaron seis sesiones de hemodiafiltraci&#243;n posdiluci&#243;n con el dializador de polisulfona HF80<span class="elsevierStyleSup">&#174;</span> y anticoagulaci&#243;n habitual con nadroparina&#44; y seis sesiones con el dializador AN69ST<span class="elsevierStyleSup">&#174;</span> de poliacrilonitrilo con una cubierta de heparina sin el uso de anticoagulaci&#243;n sist&#233;mica&#46; Evaluamos cada hora el grado de coagulaci&#243;n del dializador y del circuito extracorp&#243;reo mediante una escala visual y las variaciones en los par&#225;metros de coagulaci&#243;n&#44; entre los que se incluy&#243; el factor anti-Xa&#46; Nuestro objetivo primario fue valorar las variaciones en la actividad del factor anti-Xa en ausencia de diferencias en la tasa de coagulaci&#243;n masiva entre los dos grupos&#46; <span class="elsevierStyleBold">Resultados&#58;</span> No se coagul&#243; el dializador de forma completa o grado 4 en ninguna de las 36 sesiones realizadas con cada dializador&#46; Se produjo una coagulaci&#243;n parcial del dializador inferior del 25&#37; &#40;grado 1-2&#41; en 32 &#40;88&#44;9&#37;&#41; sesiones con AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;y 35 &#40;97&#44;2&#37;&#41; con el dializador habitual&#44; y superior del 25&#37; &#40;grado 3-4&#41; en 4 &#40;11&#44;1&#37;&#41; sesiones con AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;y en 1 &#40;2&#44;8&#37;&#41; sesi&#243;n con el dializador con heparina&#46; La coagulaci&#243;n del atrapaburbujas arterial no fue superior al 25&#37; &#40;grados 3 y 4&#41; en ninguna de las sesiones estudiadas&#44; y la c&#225;mara venosa en s&#243;lo 1 &#40;2&#44;8&#37;&#41; sesi&#243;n con el dializador habitual y 3 &#40;8&#44;4&#37;&#41; con AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;sin diferencias entre los dos dializadores&#46; El valor del tiempo de tromboplastina parcial activada present&#243; diferencias a las dos horas entre ambas t&#233;cnicas&#44; relacionadas con la administraci&#243;n de la heparina de bajo peso molecular &#40;33&#44;3 &#177; 2&#44;7 s con polisulfona y 27&#44;5 &#177; 2&#44;3 s en AN69ST<span class="elsevierStyleSup">&#174;</span>&#44; p &#60; 0&#44;05&#41;&#44; que continuaron siendo significativas al finalizar la sesi&#243;n &#40;29&#44;8 &#177; 2&#44;1 s con polisulfona y 27&#44;2 &#177; 1&#44;8 s con AN69ST<span class="elsevierStyleSup">&#174;</span>&#44; p &#60; 0&#44;05&#41;&#46; La actividad del factor anti-Xa fue m&#225;xima dos horas despu&#233;s de la administraci&#243;n de nadroparina&#44; con diferencias entre ambos dializadores &#40;0&#44;46 &#177; 0&#44;13 UI&#47;ml en di&#225;lisis con polisulfona y 0&#44;04 &#177; 0&#44;04 UI&#47;ml con AN69ST<span class="elsevierStyleSup">&#174;</span>&#44; p &#60; 0&#44;005&#41;&#44; para ir descendiendo en la determinaci&#243;n de las 4 horas &#40;0&#44;17 &#177; 0&#44;12 UI&#47;ml en di&#225;lisis con polisulfona y 0&#44;02 &#177; 0&#44;03 UI&#47;ml en AN69ST<span class="elsevierStyleSup">&#174;</span>&#44; p &#60; 0&#44;05&#41;&#46; Un paciente fue excluido del estudio al presentar una reacci&#243;n adversa caracterizada por prurito generalizado con el dializador AN69ST<span class="elsevierStyleSup">&#174;</span>&#44; motivo por el que retir&#243; en la primera sesi&#243;n el consentimiento&#46; <span class="elsevierStyleBold">Conclusi&#243;n&#58;</span> Demostramos la baja trombogenicidad del dializador AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;de forma que permite realizar sesiones de hemodiafiltraci&#243;n posdiluci&#243;n sin necesidad de anticoagulaci&#243;n sist&#233;mica&#44; y sin aumentar la frecuencia de eventos de coagulaci&#243;n grave en comparaci&#243;n con el dializador HF80<span class="elsevierStyleSup">&#174;</span>&#160;junto a nadroparina y con menor riesgo de sangrado al no modificar la actividad del factor anti-Xa&#46;</p>"
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        "resumen" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">Background&#58;</span> Hemodialysis systems are potentially thrombogenic&#44; so it is routinely used anticoagulation&#46; Its prescription is with risks though which the recommendations regarding the scheduled dose are still based on very different criteria&#46; <span class="elsevierStyleBold">Methods&#58;</span> We performed a randomized&#44; crossover pilot study&#46; Six patients underwent six sessions of post-dilution hemodiafiltration with polysulfone HF80<span class="elsevierStyleSup">&#174;</span> dialyzer and standard anticoagulation with nadroparin&#44; and six sessions with heparin-coated poliacrylonitrile AN69ST<span class="elsevierStyleSup">&#174;</span> membrane without using systemic anticoagulation&#46; Dialyser and the extracorporeal circuit clotting grade was evaluated through visual scale every hour and coagulation parameters like anti-Xa factor&#46; Our endpoint was to assess anti-Xa activity without differences in the rate of massive clotting between the two groups&#46; <span class="elsevierStyleBold">Results&#58;</span> No complete or grade 4 dialyzer clotting occurred in any of 36 sessions with each dialyzer&#46; A partial lower 25&#37; &#40;grade 1-2&#41; dialyzer clotting was in 32 &#40;88&#46;9&#37;&#41; AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;sessions and 35 &#40;97&#46;2&#37;&#41; with the usual dialyzer and upper 25&#37; &#40;grade 3-4&#41; in 4 &#40;11&#46;1&#37;&#41; AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;sessions and 1 &#40;2&#46;8&#37;&#41; dialysis session with heparin&#46; Arterial chamber blood coagulation was not greater than 25&#37; &#40;grade 3 and 4&#41; in any of the studied sessions and the venous chamber in only 1 &#40;2&#46;8&#37;&#41; session with the usual dialyzer and 3 &#40;8&#46;4&#37;&#41; with no differences AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;between the two dialyzers&#46; The activated partial thromboplastin time at two hours showed differences between techniques related to administration of low molecular weight heparin &#40;33&#46;3&#177;2&#46;7 s with polysulfone and 27&#46;5&#177;2&#46;3 s in AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;p&#60;&#46;05&#41; which remained significant at the end of the session &#40;29&#46;8&#177;2&#46;1 s with polysulfone and 27&#46;2&#177;1&#46;8 s with AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;p&#60;0&#46;05&#41;&#46; Anti-Xa factor activity was maximal two hours after administration of nadroparin&#44; with differences between the two dialyzers &#40;0&#46;46&#177;0&#46;13 IU &#47; ml in dialysis with polysulfone and 0&#46;04 &#177; 0&#46;04 IU &#47; ml with AN69ST<span class="elsevierStyleSup">&#174;</span>p&#60;0&#46;005&#41; and went down after 4 hours &#40;0&#46;17&#177;0&#46;12IU &#47; ml in dialysis with polysulfone and 0&#46;02&#177;0&#46;03IU &#47; ml in AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;p&#60;0&#46;05&#41;&#46; One patient in dialysis AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;had an adverse reaction characterized by generalized pruritus and was excluded from the study&#44; by withdrawing the consent in the first session&#46; <span class="elsevierStyleBold">Conclusion&#58;</span> We demonstrate the low thrombogenicity of the AN69ST<span class="elsevierStyleSup">&#174;</span>&#160;dialyzer that allows post-dilution hemodiafiltration sessions without systemic anticoagulation&#44; and without increasing the frequency of severe clotting events compared to HF80<span class="elsevierStyleSup">&#174;</span>&#160;dialyzer with nadroparin and with less risk of bleeding by not modifying the anti-Xa factor activity&#46;</p>"
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Article information
ISSN: 20132514
Original language: English
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