Plasma Transfusion in Liver Transplantation
Phase 4
Completed
- Conditions
- Bleeding in Liver Transplantation
- Interventions
- Other: plasma
- Registration Number
- NCT00235183
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Quarantined FFP plasma Quarantined FFP Methylene blue FFP plasma Methylene blue FFP Solvent detergent FFP plasma Solvent detergent FFP
- Primary Outcome Measures
Name Time Method Volume of transfused plasma during surgery 5 years
- Secondary Outcome Measures
Name Time Method correction of coagulation abnormalities 5 years immediate and delayed adverse events 15 days
Trial Locations
- Locations (1)
EFS
🇫🇷Paris, France