NCT01539057

The Efficacy of the Administration of Fibrinogen in Liver Transplantation

A Multicenter, Placebo Controlled Study to Evaluate the Efficacy of the Administration of Fibrinogen on Blood Product Requirements in Liver Transplantation

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Methods: A multicenter, randomized, double-blind, placebo-controlled study. One hundred thirty two patients (132) will randomly be assigned to: Treatment group, Fibrinogen administration; doses of fibrinogen: 1 g for an increase in the plasmatic value of fibrinogen of 0.29 g / L to obtain a value of 2.9 g / L. Placebo group, to whom the same dose volume of saline will be administered. Determinations of haematocrit, electrolytes and kidney function tests and coagulation and haemostasis and thrombelastography test are made at all stages of the proceeding. A standard protocol for intraoperative management will be applied. Blood loss, administration of blood products, fluid therapy, presence of reperfusion syndrome, operative complications and mortality and survival will be registered. Patients will be followed for one year after transplantation.

Conditions

• Intraoperative Bleeding

Interventions

Type	Name	Description
DRUG	Fibrinogen	The dose of fibrinogen should be calculated at 1 g of fibrinogen in order to obtain an increase in plasma fibrinogen value of 0.29 g / L to reach a final value of 2.9 g / L. Fibrinogen ampoules powder prepared with water dilution and located in a serum at a concentration of 2g/100 ml, which will be administered by intravenous infusion for 10 minutes. Administration before surgery starts
DRUG	Saline	the same dose in volume of water dilution will be administered. The potential dose of fibrinogen required to obtain a final plasmatic reading of 2.9 g / L. will be computed. A serum will contain the corresponding ml of water dilution. Administered before surgery starts

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-09-01
• Completion: 2015-01-01
• First posted: 2012-02-27
• Last updated: 2014-12-04

Locations

4 sites across 1 country: Spain