Citrate Anticoagulation vs. Heparin-Coated Dialyzers - Full Text View

Sponsor:	Universitaire Ziekenhuizen Leuven
Information provided by:	Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:	NCT00395824

Purpose

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	Intervention	Phase
Dialysis	Procedure: anticoagulation procedure	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Dialysis

Drug Information available for: Citric acid Sodium Citrate Heparin

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:

anticoagulation efficacy as evaluated by clotting score of dialyser
anticoagulation efficacy as evaluated by occurrence of major and minor clotting events
anticoagulation efficacy as evaluated by instantaneous blood clearances

Secondary Outcome Measures:

anticoagulation efficay as evaluated by time course of coagulation parameters

Estimated Enrollment:	33
Study Start Date:	January 2005
Estimated Study Completion Date:	September 2005

Detailed Description:

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.
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®).
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.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395824

Locations

Belgium
University Hopsital Leuven
Leuven, Belgium, 3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

Principal Investigator:

Pieter Evenepoel, MD, PhD

Universitaire Ziekenhuizen Leuven

More Information

No publications provided by Universitaire Ziekenhuizen Leuven

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Evenepoel P, Dejagere T, Verhamme P, Claes K, Kuypers D, Bammens B, Vanrenterghem Y. Heparin-coated polyacrylonitrile membrane versus regional citrate anticoagulation: a prospective randomized study of 2 anticoagulation strategies in patients at risk of bleeding. Am J Kidney Dis. 2007 May;49(5):642-9.

ClinicalTrials.gov Identifier:	NCT00395824 History of Changes
Other Study ID Numbers:	pe2006-01
Study First Received:	November 2, 2006
Last Updated:	November 2, 2006
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by Universitaire Ziekenhuizen Leuven:

citrate
anticoagulation
heparin-coated membrane

Additional relevant MeSH terms:

Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012