Citrate Anticoagulation During MARS Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00695617
First received: June 10, 2008
Last updated: March 4, 2009
Last verified: March 2009
  Purpose

The optimal anticoagulation procedure during MARS treatment has not been defined. In various multi-centre trials, such as MARS-RELIEF, anticoagulation procedures are left to the discretion of the treating physician. On the one hand, given the increased risk of bleeding associated with liver failure, high dosage of anticoagulation therapy should be avoided. On the other hand, contact of blood or blood components with the extracorporeal circuit will likely result in coagulation activation or even loss of coagulation factors.

Citrate anticoagulation has gained popularity, especially in hemodialysis patients. It results in a highly effective anticoagulation, exclusively confined to the extracorporeal circulation. Moreover, dependent on the type of dialyser membrane, citrate anticoagulation resulted in reduced activation of other cellular components.

In contrast to hemodialysis patients, experience with citrate anticoagulation during treatment with artificial liver devices is limited. The liver contributes substantially to the metabolism of exogenous citrate. As a result, cirrhotic patients have decreased endogenous citrate clearances. Importantly, blood purification devices contribute substantially to overall citrate clearance, thereby preventing accumulation of citrate. Several centres, including our own, have gained experience with citrate anticoagulation during fractionated plasma separation and adsorption (FPSA), a related liver dialysis device, in the treatment of liver failure patients.

Citrate anticoagulation during MARS treatment has not been studied so far.


Condition Intervention Phase
Liver Failure
Drug: trisodiumcitrate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Citrate Anticoagulation During MARS Treatment

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Extracorporeal circuit coagulation events [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Citrate tolerability [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
  • Treatment efficacy [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: July 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
citrate first
Drug: trisodiumcitrate
trisodiumcitrate 1.035 M
Experimental: B
no anticoagulation first
Drug: trisodiumcitrate
trisodiumcitrate 1.035 M

  Eligibility

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

Inclusion Criteria:

  • Scheduled MARS treatment
  • Age over 18 years
  • Informed consent
  • Admitted to Intensive Care Unit

Exclusion Criteria:

  • Blood or plasma transfusion within 48 hours before study
  • Hypocalcemia (ionised Ca < 0.90 mmol/l)
  • Acidosis (pH < 7.25) due to any cause
  • Use of citrate containing medications
  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: NCT00695617

Contacts
Contact: Pieter Evenepoel, MD, PhD +32 16 344580 pieter.evenepoel@uz.kuleuven.ac.be
Contact: Bjorn Meijers, MD +32 16 342352 bjorn.meijers@uz.kuleuven.ac.be

Locations
Belgium
Universitaire Ziekenhuizen Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Björn Meijers, MD    +32 16 342352    bjorn.meijers@uz.kuleuven.ac.be   
Principal Investigator: Bjorn Meijers, MD         
Principal Investigator: Pieter Evenepoel, MD, PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Pieter Evenepoel, MD, PhD University Hospitals Leuven
Principal Investigator: Bjorn Meijers, MD University Hospitals Leuven
Principal Investigator: Alexander Wilmer, MD, PhD University Hospitals Leuven
Principal Investigator: Frederik Nevens, MD, PhD University Hospitals Leuven
  More Information

Publications:
Responsible Party: Pieter Evenepoel, University Hospitals Leuven
ClinicalTrials.gov Identifier: NCT00695617     History of Changes
Other Study ID Numbers: ML4960
Study First Received: June 10, 2008
Last Updated: March 4, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitaire Ziekenhuizen Leuven:
MARS treatment
Citrate anticoagulation

Additional relevant MeSH terms:
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014