Effect of Nephral 400 ST Dialysis Membrane on Coagulation in Hemodialysis

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether the dialysis filter AN69ST (Nephral 400 ST Dialysis Membrane) induces less clotting during hemodialysis than a conventional polysulphone filter. Our hypothesis is that the two filters induce the same degree of clotting.

Detailed Description
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Six consecutive hemodialysis (HD) sessions are evaluated per patient, altogether 10 - 12 stable HD patients (or at least 48 HD sessions altogether). During these six sessions, AN69ST and Fx8 are used on alternate days. Dalteparin is given intravenously as a single bolus dose at start of HD (50% of the conventional dose). Clinical clotting is evaluated visually each hour of HD after blood draining of the venous air trap: 1=no clot, 2=a fibrinous ring, 3=a clot <1 cm, 4=a clot >1 cm and 5=coagulated system (stop in HD). Blood specimens are taken at start and after each hour of HD. Markers of coagulation (prothrombin 1+2) and of platelets (beta-thromboglobulin) are evaluated as well as anti FXa-activity. The two filters are going to be compared statistically with respect to the degree of clinical clotting and of intravascular coagulation and platelets activation.

Official Title
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A Comparing Study of Nephral 400 ST and Fx8 Dialysis Membranes on Coagulation During Hemodialysis

Conditions
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Extracorporeal Clotting During Hemodialysis

Intervention / Treatment
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* Device: AN69ST dialysis membrane
* Device: Fx8 (Fresenius)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient aged 18 years or more having been in chronic HD for at least 1 month dialysis time at least 4 hours 3 times per week blood flow at least 200 ml/min Fragmin dose unchanged the last week before study start Fragmin given intravenously as one single dose at HD start Haemoglobin >= 11.0 g/dL and stable +/- 20% the last week before study start erythropoietin and iron dose unchanged the last week before study start written and orally informed consent given by the patient Exclusion Criteria: treatment with acetylsalicylic acid (ASA) use of Warfarin or another oral anticoagulant clinical signs of infection disseminated malignant disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1: AN69ST<br>Hemodialysis sessions with use of the dialysis filter AN69ST. | Device: AN69ST dialysis membrane<br>* AN69ST is the filter that the blood goes through during hemodialysis<br>|
| Active Comparator: 2:Fx8<br>Hemodialysis sessions with use of the dialysis filter Fx8 | Device: Fx8 (Fresenius)<br>* Polysulphone dialysis membrane<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical clotting in the air trap |  | 14 days (6 consecutive HD sessions) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravascular coagulation and platelet activation |  | 14 days (6 HD sessions) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clotting, hemodialysis, anticoagulation, bleeding risk