NCT00235183CompletedPhase 4
Plasma Transfusion in Liver Transplantation : a Randomized, Double Blind, Multicenter Trial of Methylene Blue, Solvent/Detergent and Quarantined Plasma.
Etablissement Français du Sang1 site in 1 country300 target enrollmentStarted: June 1, 2005Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Volume of transfused plasma during surgery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Quarantined FFP
Active Comparator
Quarantined FFP
Intervention: plasma (Other)
Methylene blue FFP
Active Comparator
Methylene blue FFP
Intervention: plasma (Other)
Solvent detergent FFP
Active Comparator
Solvent detergent FFP
Intervention: plasma (Other)
Outcomes
Primary Outcomes
Volume of transfused plasma during surgery
Time Frame: 5 years
Secondary Outcomes
- correction of coagulation abnormalities(5 years)
- immediate and delayed adverse events(15 days)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Prehospital Transfusion Strategy in Bleeding PatientsHemorrhageBlood Component TransfusionNCT04879485University of Aarhus120
Unknown
Not Applicable
Effect of Transfusion of Plasma on Endothelial During Liver TransplantationLiver TransplantationEnd Stage Liver DIseaseNCT04107883Beijing Chao Yang Hospital30
Completed
Not Applicable
Study of Sequential Perfusion of Liver Grafts to Prevent Nonanastomotic Biliary Strictures After Liver TransplantationLiver TransplantationTransplant RecipientNCT01271179Shanghai Jiao Tong University School of Medicine141
Completed
Not Applicable
Plasma Exchange for Amanita Toxin-induced Acute Liver FailureAcute Liver FailureNCT06187220Hannover Medical School111
Completed
Phase 4
Strategy of Transfusion in Trauma Patients - STATA TrialWounds and InjuriesNCT02416817University of Sao Paulo General Hospital156