The Efficacy of the Administration of Fibrinogen in Liver Transplantation (FibstudLT)

Catalan Institute of Health

Status and phase: Unknown; Phase 3

Conditions: Intraoperative Bleeding

Treatments: Drug: Fibrinogen; Drug: Saline

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01539057

Promotor Code 1553-H-459

2010-024584-41 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 2 patient groups, including a placebo group

Intravenous Fibrinogen

Experimental group

Description:

Fibrinogen will be administered until an expected plasmatic value of 2.9 g / L is achieved.

Treatment:

Drug: Fibrinogen

Saline Serum

Placebo Comparator group

Description:

the same dose in volume of saline 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 saline dilution

Treatment:

Drug: Saline