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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
History of Changes

June 10, 2008
March 4, 2009
July 2008
December 2009   (final data collection date for primary outcome measure)
Extracorporeal circuit coagulation events [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00695617 on ClinicalTrials.gov Archive Site
  • Citrate tolerability [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
  • Treatment efficacy [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Citrate Anticoagulation During MARS Treatment
Citrate Anticoagulation During MARS Treatment

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Failure
Drug: trisodiumcitrate
trisodiumcitrate 1.035 M
  • Experimental: A
    citrate first
    Intervention: Drug: trisodiumcitrate
  • Experimental: B
    no anticoagulation first
    Intervention: Drug: trisodiumcitrate
Meijers BK, Verhamme P, Nevens F, Hoylaerts MF, Bammens B, Wilmer A, Arnout J, Vanrenterghem Y, Evenepoel P. Major coagulation disturbances during fractionated plasma separation and adsorption. Am J Transplant. 2007 Sep;7(9):2195-9. Epub 2007 Jul 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Belgium
 
NCT00695617
ML4960
No
Pieter Evenepoel, University Hospitals Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
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
Universitaire Ziekenhuizen Leuven
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP