Bleeding in Liver Transplantation
Conditions
Keywords
plasma, bleeding, liver transplantation
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.
Interventions
OTHERplasma
transfusion of more than 15 mL/Kg of plasma
Sponsors
Etablissement Français du Sang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volume of transfused plasma during surgery | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| correction of coagulation abnormalities | 5 years |
| immediate and delayed adverse events | 15 days |
Countries
France
Outcome results
None listed