The Efficacy of the Administration of Fibrinogen in Liver Transplantation

• Status: Unknown status
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitari de Bellvitge
• Collaborators: Spanish Clinical Research Network - CAIBER; Spanish Clinical Research Network - SCReN

Criteria

Inclusion Criteria:

• Patients candidates for liver transplantation

• Patients with a value of pre-transplant plasma fibrinogen less than 2.9 g / L.

Exclusion Criteria:

• Patients with a value of fibrinogen in the 24 hours prior to the intervention than 2.9 g / L.

• Known history of thromboembolic events in 30 days

• Known or suspected pregnancy

• Previous randomization in this trial

• Known or suspected allergy to trial products or related products

• Known presence of congenital bleeding disorder. Patients treated with aspirin, warfarin

• The following indications for transplantation: familial polyneuropathy, acute liver failure, biliary cirrhosis and sclerosing cholangitis, Budd-Chiari syndrome

• Heart beating donors and living donor

• Patient reluctant to participate in the trial