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Plasma Transfusion in Liver Transplantation

This study has been completed.
Sponsor:
Information provided by:
Etablissement Français du Sang
ClinicalTrials.gov Identifier:
NCT00235183
First received: October 6, 2005
Last updated: July 1, 2011
Last verified: July 2011
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Plasma Transfusion in Liver Transplantation : a Randomized, Double Blind, Multicenter Trial of Methylene Blue, Solvent/Detergent and Quarantined Plasma.

Resource links provided by NLM:

U.S. FDA Resources

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
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Quarantined FFP
Quarantined FFP
 Other: plasma
transfusion of more than 15 mL/Kg of plasma
Active Comparator: Methylene blue FFP
Methylene blue FFP
 Other: plasma
transfusion of more than 15 mL/Kg of plasma
Active Comparator: Solvent detergent FFP
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

Locations
France
EFS
Paris, France, 75015
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: President of EFS, Etablissement Français du Sang
ClinicalTrials.gov Identifier: NCT00235183     History of Changes
Other Study ID Numbers: EFS plasma trial
Study First Received: October 6, 2005
Last Updated: July 1, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Etablissement Français du Sang:
plasma
bleeding
liver transplantation

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Methylene Blue
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013