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Plasma Transfusion in Liver Transplantation

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ClinicalTrials.gov Identifier: NCT00235183
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : February 17, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bleeding in Liver Transplantation Other: plasma Phase 4

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : June 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Volume of transfused plasma during surgery [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. correction of coagulation abnormalities [ Time Frame: 5 years ]
  2. immediate and delayed adverse events [ Time Frame: 15 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Etablissement Français du Sang
ClinicalTrials.gov Identifier: NCT00235183     History of Changes
Other Study ID Numbers: EFS plasma trial
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: February 17, 2014
Last Verified: February 2014

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