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

This study is currently recruiting participants.
Verified May 2013 by Hospital Universitari de Bellvitge
Sponsor:
Collaborator:
Spanish Clinical Research Network - CAIBER
Information provided by (Responsible Party):
Antoni Sabate, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01539057
First received: February 2, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Intraoperative Bleeding
 Drug: Fibrinogen
Drug: Saline
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Drug Information available for: Fibrinogen
U.S. FDA Resources

Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • Percentage of patients requiring transfusion of packed red blood cells during the procedure [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    • Operative mortality
    • Liver graft survival
    • Thrombotic complications of all types and causes

  • liver transplantation outcome [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Follow-up of graft survival and patient mortality one year after liver transplantation.


Estimated Enrollment: 132
Study Start Date: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: physiologic serum

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539057

Contacts
Contact: Antoni Sabate, MD 34-3-2607323 asabatep@bellvitgehospital.cat

Locations
Spain
Hospital de Cruces Recruiting
Bilbao, Vizcaya, Spain
Principal Investigator: Rosa Gutierrez, MD            
Hospital Universitari de Bellvitge Recruiting
Barcelona, Spain, 08907
Contact: Antoni Sabate, PhD MD         asabatep@bellvitgehospital.cat    
Principal Investigator: Antoni Sabate, MD            
Hospital Clinic Recruiting
Barcelona, Spain, 08 005
Principal Investigator: Joan Beltran, MD            
Hospital Virgen de la Arrixaca Recruiting
Murcia, Spain
Principal Investigator: Francisco Acosta, MD            
Hospital Virgen del Rocio Recruiting
Sevilla, Spain
Principal Investigator: Juan Luis Lopez-Romero, MD            
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Spanish Clinical Research Network - CAIBER
Investigators
Study Director: Antoni Sabate, MD Hospital Universitari Bellvitge.IDIBELL
  More Information

No publications provided

Responsible Party: Antoni Sabate, Head of Anesthesiology, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01539057     History of Changes
Other Study ID Numbers: Promotor Code 1553-H-459, 2010-024584-41
Study First Received: February 2, 2012
Last Updated: May 6, 2013
Health Authority: Spain: Ministry of Health

Keywords provided by Hospital Universitari de Bellvitge:
Liver
Surgery
hemostasis
coagulation
Fibrinogen

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications

ClinicalTrials.gov processed this record on May 19, 2013