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Completed

NCT Number: NCT01388270

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

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.

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Key information

Conditions

Renal Failure Cardiovascular Diseases Embolism and Thrombosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Thrombosis Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of nephrology, Oslo University Hospital, Ullevål

Oslo, 0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

a pre-heparin-coated hemodialysis filter; Hepran

Device

Use of the pre-heparin-coated filter compared to the conventional filter in a cross over design

Other names: HeprAN membrane, polyacrylonitrile, heparin-grafted membrane

Primary outcomes

  1. Activation of the intravascular coagulation system during hemodialysis with use of a pre-heparin-coated filter compared to a conventional filter

    Time frame: Activation of the intravascular coagulation system is assessed during four dialysis sessions within a two weeks period for a single patient

    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.

Secondary outcomes

  1. 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.

    Time frame: 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

    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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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)

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Jul 6, 2011
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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