FibstudLT: The Efficacy of the Administration of Fibrinogen in Liver Transplantation

Sponsor

Hospital Universitari de Bellvitge (Other)

Overall Status

Unknown status

CT.gov ID

NCT01539057

Collaborator

Spanish Clinical Research Network - SCReN (Other)

132

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intraoperative Bleeding	Drug: Fibrinogen Drug: Saline	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Sep 1, 2013

Anticipated Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intravenous Fibrinogen Fibrinogen will be administered until an expected plasmatic value of 2.9 g / L is achieved.	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 Other Names: Haemocomplettan RiaSTAP
Placebo Comparator: Saline Serum 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	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 Other Names: physiologic serum

Arm

Intervention/Treatment

Experimental: Intravenous Fibrinogen

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

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

Other Names:

Haemocomplettan

RiaSTAP

Placebo Comparator: Saline Serum

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

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

Other Names:

physiologic serum

Outcome Measures

Primary Outcome Measures

Percentage of patients requiring transfusion of packed red blood cells during the procedure [intraoperative]
record of number of red blood cell packeds transfused during the surgical procedure

Secondary Outcome Measures

Percentage of patients requiring blood products other than red cell concentrates [intraoperative]
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
Operative outcome [4 weeks]
Operative mortality Liver graft survival Thrombotic complications of all types and causes
liver transplantation outcome [1 year]
Follow-up of graft survival and patient mortality one year after liver transplantation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Cruces	Bilbao	Vizcaya	Spain
2	Hospital Universitari de Bellvitge	Barcelona		Spain	08907
3	Hospital Virgen de la Arrixaca	Murcia		Spain
4	Hospital Virgen del Rocio	Sevilla		Spain