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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Antoni Sabate, Hospital Universitari de Bellvitge.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01539057
First Posted: February 27, 2012
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Spanish Clinical Research Network - CAIBER
Information provided by (Responsible Party):
Antoni Sabate, Hospital Universitari de Bellvitge
  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
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

Resource links provided by NLM:


Further study details as provided by Antoni Sabate, Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • Percentage of patients requiring transfusion of packed red blood cells during the procedure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 4 weeks ]
    • Operative mortality
    • Liver graft survival
    • Thrombotic complications of all types and causes

  • liver transplantation outcome [ Time Frame: 1 year ]
    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: January 2015
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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539057


Locations
Spain
Hospital de Cruces
Bilbao, Vizcaya, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain, 08907
Hospital Virgen de la Arrixaca
Murcia, Spain
Hospital Virgen del Rocio
Sevilla, Spain
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Spanish Clinical Research Network - CAIBER
Investigators
Study Director: Antoni Sabate, MD Hospital Universitari Bellvitge.IDIBELL
  More Information

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 ( EudraCT Number )
First Submitted: February 2, 2012
First Posted: February 27, 2012
Last Update Posted: December 4, 2014
Last Verified: December 2014

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

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