drugset / Trial / NCT01539057
The Efficacy of the Administration of Fibrinogen in Liver Transplantation
Phase 3
Unknown
132 enrolled
Hospital Universitari de Bellvitge
Spanish Clinical Research Network - SCReN · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Objective: * To evaluate the efficacy of preoperative administration of fibrinogen in liver transplantation by maintaining a preoperative plasma level equal to 2.9 g / L compared with placebo, reflecting a reduction in the number of RBC units transfused during the procedure. * To determine the influence of fibrinogen administration on mortality and survival of liver graft evaluated one year after the procedure. * To determine the safety of fibrinogen administration recording thrombotic complications evaluated during hospitalization or at least 30 days postoperatively.
Timeline
- Start
- 2012-07
- Primary completion
- 2013-09
- Completion
- 2015-01
Publications
- Perez L, Sabate A, Gutierrez R, Caballero M, Pujol R, Llaurado S, Penafiel J, Hereu P, Blasi A. Risk factors associated with blood transfusion in liver transplantation. Sci Rep. 2024 Aug 16;14(1):19022. doi: 10.1038/s41598-024-70078-2.
- Caballero M, Sabate A, Perez L, Vidal J, Reverter E, Gutierrez R, Crespo G, Penafiel J, Blasi A. Factors associated with mechanical ventilation longer than 24 h after liver transplantation in patients at risk for bleeding. BMC Anesthesiol. 2023 Nov 2;23(1):356. doi: 10.1186/s12871-023-02321-8.
- Blasi A, Sabate A, Beltran J, Costa M, Reyes R, Torres F. Correlation between plasma fibrinogen and FIBTEM thromboelastometry during liver transplantation: a comprehensive assessment. Vox Sang. 2017 Nov;112(8):788-795. doi: 10.1111/vox.12598. Epub 2017 Oct 8.
- Sabate A, Gutierrez R, Beltran J, Mellado P, Blasi A, Acosta F, Costa M, Reyes R, Torres F. Impact of Preemptive Fibrinogen Concentrate on Transfusion Requirements in Liver Transplantation: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Am J Transplant. 2016 Aug;16(8):2421-9. doi: 10.1111/ajt.13752. Epub 2016 Mar 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fibrinogen Concentrate Human | Protein / enzyme biologic | 1 g | Intravenous |