Plasma Transfusion in Liver Transplantation

Phase 4

Completed

• Conditions: Bleeding in Liver Transplantation

• Registration Number: NCT00235183
• Lead Sponsor: Etablissement Français du Sang

Brief Summary

The aim of the study is to compare the clinical efficacy of three types of plasma secured on the viral level either by quarantine or by chemical treatment in patients undergoing liver transplantation.

Detailed Description

Three types of plasma are transfused in bleeding patients undergoing liver transplantation:

* quarantined plasma,

* methylene blue treated plasma,

* solvent/detergent plasma. The main purpose is to show that the volume of methylene blue treated plasma consumed intraoperatively is equivalent to that of the 2 other types of plasma.

In addition, the correction of coagulation abnormalities are studied.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-10-06
• Study First Submitted QC: 2005-10-06
• Study First Posted: 2005-10-10
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-14
• Last Update Posted: 2014-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• age 18 yo and above
• consent is signed,
• liver transplantation is indicated,
• plasma is transfused

Exclusion Criteria

• multiorgan transplantation (except combined kidney and liver transplantation)
• allergy to methylene blue.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Volume of transfused plasma during surgery	5 years

Secondary Outcome Measures

Name	Time	Method
correction of coagulation abnormalities	5 years
immediate and delayed adverse events	15 days

Trial Locations

Locations (1)

EFS; 🇫🇷 Paris, France