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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | citrate first |
|
| B | Experimental | no anticoagulation first |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trisodiumcitrate | Drug | trisodiumcitrate 1.035 M |
| |
| trisodiumcitrate |
| Measure | Description | Time Frame |
|---|---|---|
| Extracorporeal circuit coagulation events | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Citrate tolerability | 6 hours | |
| Treatment efficacy | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pieter Evenepoel, MD, PhD | Contact | +32 16 344580 | pieter.evenepoel@uz.kuleuven.ac.be | |
| Bjorn Meijers, MD | Contact | +32 16 342352 | bjorn.meijers@uz.kuleuven.ac.be |
| Name | Affiliation | Role |
|---|---|---|
| Pieter Evenepoel, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Bjorn Meijers, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaire Ziekenhuizen Leuven | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17640311 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 14, 2011 | |
| Reset | Oct 21, 2011 | |
| Release | May 2, 2017 | |
| Reset | Sep 29, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 14, 2011 | Oct 21, 2011 | |||
| May 2, 2017 |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Drug |
trisodiumcitrate 1.035 M |
|
| Alexander Wilmer, MD, PhD |
| Universitaire Ziekenhuizen KU Leuven |
| Principal Investigator |
| Frederik Nevens, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Sep 29, 2017 |