Citrate Anticoagulation During MARS Treatment

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Unknown status

CT.gov ID

NCT00695617

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Liver Failure	Drug: trisodiumcitrate Drug: trisodiumcitrate	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Citrate Anticoagulation During MARS Treatment

Study Start Date :

Jul 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A citrate first	Drug: trisodiumcitrate trisodiumcitrate 1.035 M
Experimental: B no anticoagulation first	Drug: trisodiumcitrate trisodiumcitrate 1.035 M

Arm

Intervention/Treatment

Experimental: A

citrate first

Drug: trisodiumcitrate

trisodiumcitrate 1.035 M

Experimental: B

no anticoagulation first

Drug: trisodiumcitrate

trisodiumcitrate 1.035 M

Outcome Measures

Primary Outcome Measures

Extracorporeal circuit coagulation events [6 hours]

Secondary Outcome Measures

Citrate tolerability [6 hours]
Treatment efficacy [6 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Universitaire Ziekenhuizen Leuven	Leuven	Vlaams-Brabant	Belgium	3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

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