Plasma Transfusion in Liver Transplantation

February 14, 2014 updated by: Etablissement Français du Sang

Plasma Transfusion in Liver Transplantation : a Randomized, Double Blind, Multicenter Trial of Methylene Blue, Solvent/Detergent and Quarantined Plasma.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • EFS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Quarantined FFP
Other: plasma
transfusion of more than 15 mL/Kg of plasma
Active Comparator: Methylene blue FFP
Other: plasma
transfusion of more than 15 mL/Kg of plasma
Active Comparator: Solvent detergent FFP
Other: plasma
transfusion of more than 15 mL/Kg of plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Volume of transfused plasma during surgery
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
correction of coagulation abnormalities
Time Frame: 5 years
5 years
immediate and delayed adverse events
Time Frame: 15 days
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Etablissement Français du Sang

Investigators

  • Principal Investigator: Yves Ozier, MD, PhD, Hôpital Cochin, Paris, France
  • Principal Investigator: Emmanuel Samain, MD, PhD, hôpital Jean Minjoz, Besançon, France
  • Principal Investigator: Marie - Christine Gillon, MD, Hôpital Paul Brousse, Villejuif, France
  • Principal Investigator: Loïc Villalon, MD, Hôpital Pontchaillou

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 6, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

February 17, 2014

Last Update Submitted That Met QC Criteria

February 14, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFS plasma trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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