Last reviewed · How we verify
NCT00695617
Citrate Anticoagulation During MARS Treatment
Phase 2/Phase 3 trial testing trisodiumcitrate in Liver Failure in 10 participants. Status unknown.
1 December 2009
Quick facts
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 1 July 2008 |
| Primary completion | 1 December 2009 |
| Estimated completion | 1 December 2009 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- trisodiumcitrate — full drug profile →
- trisodiumcitrate — full drug profile →
Conditions studied
- Liver Failure — all drugs for Liver Failure →
Sponsor
Universitaire Ziekenhuizen KU Leuven — full company profile →
Who can join
18 and older, any sex, with Liver Failure. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Extracorporeal circuit coagulation events
Time frame: 6 hours
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A prospective randomized open-label crossover trial of regional citrate anticoagulation vs. anticoagulation free liver dialysis by the Molecular Adsorbents Recirculating System.
Meijers B, Laleman W, Vermeersch P, Nevens F, et al · · 2012 · cited 30× · PMID 22305273 · DOI 10.1186/cc11180
Verify or expand the search:
- PubMed search for NCT00695617
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Liver Failure
Currently open trials in the same condition.
- NCT07312864 — Safety and Tolerability Study of a Novel Bioartificial Liver in Liver Failure and Small-for-Size Syndrome · Phase 1, PHASE2 · recruiting
- NCT06871111 — The Microbiota Augmentation to Reestablish Commensal Organisms (MARCO) Trial · Phase 1 · recruiting
- NCT07053488 — CRISPR-Edited HLA Donor Liver Transplant to Reduce Rejection · Phase 1, PHASE2 · recruiting
- NCT06908746 — Efficacy and Safety of Citrate Anticoagulation in CRRT for Patients With Liver Failure/DysfuncTION, the CAUTION Trial! A · recruiting
- NCT06224023 — Predictive Values of Presepsin Levels in ASciteS in Patients With Chronic Liver Failure · recruiting
Other Universitaire Ziekenhuizen KU Leuven trials
Trials by the same sponsor.
- NCT06831955 — LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer · Phase 2 · recruiting
- NCT07356505 — Efficacy and Safety of Micra AV2 Transcatheter Pacing System · NA · recruiting
- NCT07286968 — Gastro-Intestinal Digestion and Physiology After Bariatric Surgery · recruiting
- NCT06962137 — Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer · Phase 2 · recruiting
- NCT07270536 — Accelerated Pacing and Cardiac Filling Pressures During Exercise in Patients With Heart Failure With Preserved Ejection · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00695617 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universitaire Ziekenhuizen KU Leuven
- Last refreshed: 4 March 2009
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00695617.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing