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Citrate Anticoagulation vs. Heparin-Coated Dialyzers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00395824
Recruitment Status : Completed
First Posted : November 3, 2006
Last Update Posted : November 3, 2006
Information provided by:
Universitaire Ziekenhuizen Leuven

Brief Summary:

Hemodialysis causes contact activation of the coagulation pathway (1). For this reason, unfractionated or low molecular weight heparins are administered in daily practice to prevent thrombosis of the dialyzer and blood circuit, but the dose commonly used causes systemic anticoagulation. This can cause serious complications in patients with high risk of bleeding. Regional and low-dose heparinization, use of prostacycline, regional citrate anticoagulation (RCA), and high-flow-rate hemodialysis without anticoagulation have been shown to reduce bleeding complications. Each of these methods, however, is characterized by its own technical difficulties, limitations, or complications.

The present study aimed to compare the efficacy and safety of heparin-coated polyacrylonitrile membranes (AN69ST) and regional citrate anticoagulation in hemodialysis patients at risk of bleeding

Condition or disease Intervention/treatment Phase
Dialysis Procedure: anticoagulation procedure Phase 3

Detailed Description:
  1. Open label single centre prospective randomized trial including 33 patients aged over 18 years with chronic kidney disease stage 5 requiring intermittent hemodialysis at the University Hospital Leuven and at risk of bleeding. Exclusion criteria were: any haemostatic disorder favouring either bleeding or clotting, anti-vitamin K or heparin treatment, heparin induced thrombocytopenia and haemodynamic instability. Written informed consent before enrolment.
  2. Random allocation (by sealed enveloppe) to RCA with a calcium free dialysate (RCA-Ca0), RCA with a calcium containing dialysate (RCA-Ca1,5) or to anticoagulant-free hemodiaysis with a heparin-coated polyacrylonitrile membrane (Nephral 300ST®).
  3. At the end of each dialysis session, arterial and venous drip chambers and the filter will be inspected for visible signs of coagulation. Corresponding to the standard care at our dialysis unit, a semi-quantitative score with a range from 0 (no signs of clotting) to 4 (complete occlusion) will be used for evaluation of the dialyzer. By definition, the drip chamber will be considered clotted when a thrombus was visible after the rinse back procedure. A fibrin ring against the wall of the drip chamber will be considered normal.
  4. Blood samples for assessment of prothrombin fragment F1+2 and d-dimers will be collected from the inlet blood catheter prior to hemodialysis initiation and during hemodialysis at T15, T120 and T238.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Heparin-Coated Polyacrylonitrile Membrane Versus Regional Citrate Anticoagulation: a Prospective Randomised Study of 2 Anticoagulation Strategies in Patients at Risk of Bleeding
Study Start Date : January 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Primary Outcome Measures :
  1. anticoagulation efficacy as evaluated by clotting score of dialyser
  2. anticoagulation efficacy as evaluated by occurrence of major and minor clotting events
  3. anticoagulation efficacy as evaluated by instantaneous blood clearances

Secondary Outcome Measures :
  1. anticoagulation efficay as evaluated by time course of coagulation parameters

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • aged over 18 years
  • chronic kidney disease stage 5 requiring intermittent hemodialysis
  • at risk of bleeding
  • written informed consent

Exclusion Criteria:

  • any haemostatic disorder favouring either bleeding or clotting
  • anti-vitamin K or heparin treatment
  • heparin induced thrombocytopenia
  • haemodynamic instability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00395824

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University Hopsital Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Principal Investigator: Pieter Evenepoel, MD, PhD Universitaire Ziekenhuizen Leuven

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00395824     History of Changes
Other Study ID Numbers: pe2006-01
First Posted: November 3, 2006    Key Record Dates
Last Update Posted: November 3, 2006
Last Verified: November 2006
Keywords provided by Universitaire Ziekenhuizen Leuven:
heparin-coated membrane
Additional relevant MeSH terms:
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Calcium heparin
Citric Acid
Sodium Citrate
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents