Citrate Anticoagulation vs. Heparin-Coated Dialyzers

NCT00395824 | Completed Phase 3

• 1 other identifier: pe2006-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Dialysis

Keywords

citrate; anticoagulation; heparin-coated membrane

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• anticoagulation efficay as evaluated by time course of coagulation parameters

Interventions

anticoagulation procedure PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hopsital Leuven

Leuven, 3000, Belgium

Location

Related Publications (2)

• Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

  PMID: 38189593 DERIVED

• 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. doi: 10.1053/j.ajkd.2007.02.001.

  PMID: 17472846 DERIVED

Study Officials

• Pieter Evenepoel, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 2006
• First Posted: November 3, 2006
• Study Start: January 1, 2005
• Study Completion: September 1, 2005
• Last Updated: November 3, 2006

Record last verified: 2006-11

Locations

BE (1)