NCT00695617

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 5, 2009

Status Verified

March 1, 2009

Enrollment Period

1.4 years

First QC Date

June 10, 2008

Last Update Submit

March 4, 2009

Conditions

Liver Failure

Keywords

MARS treatmentCitrate anticoagulation

Outcome Measures

Primary Outcomes (1)

  • Extracorporeal circuit coagulation events

    6 hours

Secondary Outcomes (2)

  • Citrate tolerability

    6 hours

  • Treatment efficacy

    6 hours

Study Arms (2)

A

EXPERIMENTAL

citrate first

Drug: trisodiumcitrate

B

EXPERIMENTAL

no anticoagulation first

Drug: trisodiumcitrate

Interventions

trisodiumcitrateDRUG

trisodiumcitrate 1.035 M

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related 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. doi: 10.1111/j.1600-6143.2007.01909.x. Epub 2007 Jul 19.

    PMID: 17640311BACKGROUND

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Pieter Evenepoel, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Bjorn Meijers, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Alexander Wilmer, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Frederik Nevens, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pieter Evenepoel, MD, PhD

CONTACT

+32 16 344580pieter.evenepoel@uz.kuleuven.ac.be

Bjorn Meijers, MD

CONTACT

+32 16 342352bjorn.meijers@uz.kuleuven.ac.be

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 10, 2008

First Posted

June 12, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 5, 2009

Record last verified: 2009-03

Locations

BE(1)