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The Efficacy of the Administration of Fibrinogen in Liver Transplantation

NCT01539057 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2014-12-04

No results posted yet for this study

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.

Conditions

  • Intraoperative Bleeding

Interventions

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

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

Sponsors & Collaborators

  • Spanish Clinical Research Network - SCReN

    collaborator NETWORK

  • Hospital Universitari de Bellvitge

    lead OTHER

Principal Investigators

  • Antoni Sabate, MD · Hospital Universitari Bellvitge.IDIBELL

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-09-30
Completion
2015-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01539057 on ClinicalTrials.gov