Trials / Unknown
UnknownNCT00695617
Citrate Anticoagulation During MARS Treatment
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | trisodiumcitrate | trisodiumcitrate 1.035 M |
| DRUG | trisodiumcitrate | trisodiumcitrate 1.035 M |
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2008-06-12
- Last updated
- 2009-03-05
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT00695617. Inclusion in this directory is not an endorsement.