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Citrate Anticoagulation During MARS Treatment

Citrate Anticoagulation During MARS Treatment

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00695617
Enrollment
10
Registered
2008-06-12
Start date
2008-07-31
Completion date
2009-12-31
Last updated
2009-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Failure

Keywords

MARS treatment, Citrate anticoagulation

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.

Interventions

DRUGtrisodiumcitrate

trisodiumcitrate 1.035 M

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Extracorporeal circuit coagulation events6 hours

Secondary

MeasureTime frame
Citrate tolerability6 hours
Treatment efficacy6 hours

Countries

Belgium

Contacts

Primary ContactPieter Evenepoel, MD, PhD
pieter.evenepoel@uz.kuleuven.ac.be+32 16 344580
Backup ContactBjorn Meijers, MD
bjorn.meijers@uz.kuleuven.ac.be+32 16 342352

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026