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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Solbjørg Sagedal, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01388270
First received: June 29, 2011
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Renal Failure
Device: a pre-heparin-coated hemodialysis filter; Hepran

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 12
Study Start Date: September 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: a pre-heparin-coated hemodialysis filter; Hepran
    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
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388270

Locations
Norway
Department of nephrology, Oslo University Hospital, Ullevål Recruiting
Oslo, Norway, 0407
Contact: Solbjørg Sagedal, MD, PhD    +4722119101    uxsasc@ous-hf.no   
Principal Investigator: Solbjørg Sagedal, PhD         
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Solbjørg Sagedal, PhD Oslo University hospital, Ullevål
  More Information

No publications provided

Responsible Party: Solbjørg Sagedal, MD,PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01388270     History of Changes
Other Study ID Numbers: 2010/3019-2
Study First Received: June 29, 2011
Last Updated: September 27, 2011
Health Authority: Norway: Ethics Committee

Keywords provided by Oslo University Hospital:
Hemodialysis
Anticoagulation
Clotting
Coagulation
dalteparin
Clotting in the extracorporeal system during HD
Antithrombogenic property of Evodial HD filter
Anticoagulation during HD

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014