Citrate Anticoagulation During MARS Treatment
|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.|
|ClinicalTrials.gov Identifier: NCT00695617|
Recruitment Status : Unknown
Verified March 2009 by Universitaire Ziekenhuizen Leuven.
Recruitment status was: Recruiting
First Posted : June 12, 2008
Last Update Posted : March 5, 2009
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 or disease||Intervention/treatment||Phase|
|Liver Failure||Drug: trisodiumcitrate||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Citrate Anticoagulation During MARS Treatment|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2009|
trisodiumcitrate 1.035 M
no anticoagulation first
trisodiumcitrate 1.035 M
- Extracorporeal circuit coagulation events [ Time Frame: 6 hours ]
- Citrate tolerability [ Time Frame: 6 hours ]
- Treatment efficacy [ Time Frame: 6 hours ]
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 ClinicalTrials.gov identifier (NCT number): NCT00695617
|Contact: Pieter Evenepoel, MD, PhD||+32 16 firstname.lastname@example.org|
|Contact: Bjorn Meijers, MD||+32 16 email@example.com|
|Universitaire Ziekenhuizen Leuven||Recruiting|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Contact: Björn Meijers, MD +32 16 342352 firstname.lastname@example.org|
|Principal Investigator: Bjorn Meijers, MD|
|Principal Investigator: Pieter Evenepoel, MD, PhD|
|Principal Investigator:||Pieter Evenepoel, MD, PhD||Universitaire Ziekenhuizen Leuven|
|Principal Investigator:||Bjorn Meijers, MD||Universitaire Ziekenhuizen Leuven|
|Principal Investigator:||Alexander Wilmer, MD, PhD||Universitaire Ziekenhuizen Leuven|
|Principal Investigator:||Frederik Nevens, MD, PhD||Universitaire Ziekenhuizen Leuven|