Citrate Anticoagulation During MARS Treatment

Liver Failure Clinical Trial

Official title:

Citrate Anticoagulation During MARS Treatment

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00695617
• Other study ID #: ML4960
• Status: Unknown status
• Phase: Phase 2/Phase 3
• First received: June 10, 2008
• Last updated: March 4, 2009
• Start date: July 2008
• Est. completion date: December 2009

Study information

• Verified date: March 2009
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Pieter Evenepoel, MD, PhD
• Phone: +32 16 344580
• Email: pieter.evenepoel[@]uz.kuleuven.ac.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 10
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Failure

Intervention

Drug:
• trisodiumcitrate
trisodiumcitrate 1.035 M
• trisodiumcitrate
trisodiumcitrate 1.035 M

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extracorporeal circuit coagulation events		6 hours
Secondary	Citrate tolerability		6 hours
Secondary	Treatment efficacy		6 hours