Plasma Transfusion in Liver Transplantation - Tabular View

Tracking Information

First Received Date ^ICMJE

October 6, 2005

Last Updated Date

February 9, 2009

Start Date ^ICMJE

June 2005

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Volume of transfused plasma during surgery [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

volume equivalence between the 3 types of transfused plasma

Change History

Complete list of historical versions of study NCT00235183 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

correction of coagulation abnormalities [ Time Frame: 5 years ] [ Designated as safety issue: No ]
immediate and delayed adverse events [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

correction of coagulation abnormalities
immediate and delayed adverse events

Descriptive Information

Brief Title ^ICMJE

Plasma Transfusion in Liver Transplantation

Official Title ^ICMJE

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

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Bleeding in Liver Transplantation

Intervention ^ICMJE

Other: plasma

Study Arms / Comparison Groups

Active Comparator: Quarantined FFP
Active Comparator: Methylene blue FFP
Active Comparator: Solvent detergent FFP

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Françoise Courtois, MD	33 1 44 49 66 07	francoise.courtois@efs.sante.fr
Contact: Anne Chabanel, ScD	33 1 44 49 66 14	anne.chabanel@efs.sante.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00235183

Responsible Party

President of EFS, Etablissement Français du Sang

Study ID Numbers ^ICMJE

EFS plasma trial

Study Sponsor ^ICMJE

Etablissement Français du Sang

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Etablissement Français du Sang

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP