Effect of a Pre Heparin Coated Dialysis Filter on Coagulation During Hemodialysis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the heparin-coated dialysis filter is superior to a conventional filter during hemodialysis in twelve stable, chronic hemodialysis (HD) patients. The antithrombogenic properties of the heparin-coated dialysis filter and of the conventional filter will be compared by means of statistical tests.

Detailed Description
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In the present study twelve chronic hemodialysis (HD) patients will be included. Exclusion criteria are use of acetylsalicylic acid and/warfarin, clinical signs of infection and disseminated malignant disease. For each patient four HD sessions will be investigated; alternating with use of the pre-heparin-coated filter or the conventional filter. Dalteparin is reduced to 50% of the conventional dose and is given as one single bolus dose at start of HD. The venous drip chamber will be visually inspected for evaluation of clot score during each HD session. The filter will be visually inspected for clot score at the end of each session. Blood specimens will be drawn systematically during each HD session to evaluate platelet and coagulation activity as well as anti Factor Xa activity, haematology and urea/creatinine to evaluate dialysis effect. The antithrombogenic properties of the pre-heparin-coated filter and the conventional filter will be compared by means of statistical tests. The hypothesis is that the pre-heparin-coated filter induces significantly less clot score in the extracorporeal system during hemodialysis and also significantly less intravascular activation of the coagulation system compared to the conventional filter.

Official Title
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The Effect of a Heparin-coated Dialysis Filter (Evodial) on Clotting and Intravascular Coagulation During Hemodialysis (HD) When Compared to a Conventional Polyflux Filter (170H)

Conditions
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Renal Failure

Intervention / Treatment
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* Device: a pre-heparin-coated hemodialysis filter; Hepran


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable HD patients of at least 18 years of age. HD treatment for at least one month. Dialysis time at least 4 hours three times per week. Stable Hemoglobin value of at least 11 g/dl during the last 4 weeks. Exclusion Criteria: Use of warfarin and/or acetylsalicylic acid. Disseminated malignant disease. Clinical signs of infection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Evodial<br>a pre-heparin-coated hemodialysis filter | Device: a pre-heparin-coated hemodialysis filter; Hepran<br>* Use of the pre-heparin-coated filter compared to the conventional filter in a cross over design<br>* Other names: heparin-grafted membrane;|
| No Intervention: 170 H<br>Conventional filter | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activation of the intravascular coagulation system during hemodialysis with use of a pre-heparin-coated filter compared to a conventional filter | Blood specimens for analysis of prothrombin fragment 1+2 and beta-thromboglobulin will be drawn at start of hemodialysis and after three and four hours of all hemodialysis sessions. | Activation of the intravascular coagulation system is assessed during four dialysis sessions within a two weeks period for a single patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A secondary outcome measure is degree of clot score in the extracorporeal system during hemodialysis with use of a pre-heparin-coated filter compared to the conventional filter. | Degree of clot score will be evaluated in the venous drip chamber as follows: 1=normal (no signs of clot). 2=fibrinous ring, 3=clot and 4=stop in dialysis due to high degree of clotting | The degree of clot score in the extracorporeal system is assessed during four hemodialysis sessions that for a single patient take place within a time frame of two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Anticoagulation, Clotting, Coagulation, dalteparin, Clotting in the extracorporeal system during HD, Antithrombogenic property of Evodial HD filter, Anticoagulation during HD