Overview

This trial is active, not recruiting.

Condition intraoperative bleeding
Treatments fibrinogen, saline
Phase phase 3
Sponsor Hospital Universitari de Bellvitge
Collaborator Spanish Clinical Research Network - CAIBER
Start date July 2012
End date September 2013
Trial size 132 participants
Trial identifier NCT01539057, 2010-024584-41, Promotor Code 1553-H-459

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Fibrinogen will be administered until an expected plasmatic value of 2.9 g / L is achieved.
fibrinogen Haemocomplettan
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
(Placebo Comparator)
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
saline physiologic serum
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

Primary Outcomes

Measure
Percentage of patients requiring transfusion of packed red blood cells during the procedure
time frame: intraoperative

Secondary Outcomes

Measure
Percentage of patients requiring blood products other than red cell concentrates
time frame: intraoperative
Operative outcome
time frame: 4 weeks
liver transplantation outcome
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title A Multicenter, Placebo Controlled Study to Evaluate the Efficacy of the Administration of Fibrinogen on Blood Product Requirements in Liver Transplantation
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Hospital Universitari de Bellvitge.