Plasma Transfusion in Liver Transplantation - Full Text View

Sponsored by:	Etablissement Français du Sang
Information provided by:	Etablissement Français du Sang
ClinicalTrials.gov Identifier:	NCT00235183

Purpose

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.

Condition	Intervention	Phase
Bleeding in Liver Transplantation	Other: plasma	Phase IV

MedlinePlus related topics: Blood Transfusion and Donation Liver Transplantation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Plasma Transfusion in Liver Transplantation : a Randomized, Double Blind, Multicenter Trial of Methylene Blue, Solvent/Detergent and Quarantined Plasma.

Further study details as provided by Etablissement Français du Sang:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	300
Study Start Date:	June 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Quarantined FFP: Active Comparator Quarantined FFP	Other: plasma transfusion of more than 15 mL/Kg of plasma
Methylene blue FFP: Active Comparator Methylene blue FFP	Other: plasma transfusion of more than 15 mL/Kg of plasma
Solvent detergent FFP: Active Comparator Solvent detergent FFP	Other: plasma transfusion of more than 15 mL/Kg of plasma

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235183

Contacts

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

Locations

France
EFS	Recruiting
Paris, France, 75015
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
Principal Investigator: Françoise Courtois, MD

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	Etablissement Français du Sang ( President of EFS )
Study ID Numbers:	EFS plasma trial
Study First Received:	October 6, 2005
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00235183 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Etablissement Français du Sang:

plasma
bleeding
liver transplantation

Study placed in the following topic categories:

Hemorrhage
Methylene Blue

ClinicalTrials.gov processed this record on May 06, 2009