drugset / Trial / NCT02251041
Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL)
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to establish the effectiveness of the combined drug approach (anti-thrombin III, infliximab, apotransferrin, human recombinant erythropoietin beta, C1-inhibitor, glutathione, alfa-tocopherol, melatonin and epoprostenol)aimed to reduce ischemia-reperfusion injury during liver transplantation in eligible recipients.
Timeline
- Start
- 2014-09
- Primary completion
- 2019-02
- Completion
- 2019-08
Publications
- Background Monbaliu D, Vekemans K, Hoekstra H, Vaahtera L, Libbrecht L, Derveaux K, Parkkinen J, Liu Q, Heedfeld V, Wylin T, Deckx H, Zeegers M, Balligand E, Buurman W, van Pelt J, Porte RJ, Pirenne J. Multifactorial biological modulation of warm ischemia reperfusion injury in liver transplantation from non-heart-beating donors eliminates primary nonfunction and reduces bile salt toxicity. Ann Surg. 2009 Nov;250(5):808-17. doi: 10.1097/SLA.0b013e3181bdd787.
- Background Vekemans K, Monbaliu D, Balligand E, Heedfeld V, Jochmans I, Pirenne J, van Pelt J. Improving the function of liver grafts exposed to warm ischemia by the Leuven drug protocol: exploring the molecular basis by microarray. Liver Transpl. 2012 Feb;18(2):206-18. doi: 10.1002/lt.22446.
- Meurisse N, Mertens M, Fieuws S, Gilbo N, Jochmans I, Pirenne J, Monbaliu D. Effect of a Combined Drug Approach on the Severity of Ischemia-Reperfusion Injury During Liver Transplant: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e230819. doi: 10.1001/jamanetworkopen.2023.0819.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alfa-tocopherol | Unknown | — | Oral |
| Comparator | Antithrombin III | Protein / enzyme biologic | — | Intravenous |
| Comparator | Apotransferrin | Unknown | — | Intravenous |
| Comparator | CINRYZE | Protein / enzyme biologic | — | Intravenous |
| Comparator | Glutathione | Peptide | — | Intravenous |
| Comparator | Human recombinant erythropoietin | Protein / enzyme biologic | — | Intravenous |
| Comparator | Infliximab | Monoclonal antibody | — | Intravenous |
| Comparator | Melatonin | Small molecule | — | Oral |
| Comparator | epoprostenol | Other / unclassified | — | Other |
Indications
No indication recorded.