The Efficacy of the Administration of Fibrinogen in Liver Transplantation

Intraoperative Bleeding Clinical Trial

— FibstudLT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01539057
• Other study ID #: Promotor Code 1553-H-459
• Secondary ID: 2010-024584-41
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 2, 2012
• Last updated: December 3, 2014
• Start date: July 2012
• Est. completion date: January 2015

Study information

• Verified date: December 2014
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: January 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Intraoperative Bleeding

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Hospital de Cruces	Bilbao	Vizcaya
Spain	Hospital Virgen de la Arrixaca	Murcia
Spain	Hospital Virgen del Rocio	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	Spanish Clinical Research Network - CAIBER

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients requiring transfusion of packed red blood cells during the procedure	record of number of red blood cell packeds transfused during the surgical procedure	intraoperative	No
Secondary	Percentage of patients requiring blood products other than red cell concentrates	Number of packed red cells transfused during surgery; Number of units of fresh frozen plasma transfused during surgery; Number of platelet units transfused during surgery; Grams of fibrinogen administered during surgery	intraoperative	No
Secondary	Operative outcome	Operative mortality; Liver graft survival; Thrombotic complications of all types and causes	4 weeks	Yes
Secondary	liver transplantation outcome	Follow-up of graft survival and patient mortality one year after liver transplantation.	1 year	Yes