Trial | NCT00235183  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    plasma

  • Study Participants

    300
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.
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 Started
Jun 30
2005
Primary Completion
Dec 31
2009
Study Completion
Dec 31
2010
Last Update
Feb 17
2014
Estimate

Other plasma

transfusion of more than 15 mL/Kg of plasma

Quarantined FFP Active Comparator

Quarantined FFP

Methylene blue FFP Active Comparator

Methylene blue FFP

Solvent detergent FFP Active Comparator

Solvent detergent FFP

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.
No Results Posted