Plasma Transfusion in Liver Transplantation

Etablissement Français du Sang

Status and phase: Completed; Phase 4

Conditions: Bleeding in Liver Transplantation

Treatments: Other: plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT00235183

EFS plasma trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups

Quarantined FFP

Active Comparator group

Description:

Quarantined FFP

Treatment:

Other: plasma

Methylene blue FFP

Active Comparator group

Description:

Methylene blue FFP

Treatment:

Other: plasma

Solvent detergent FFP

Active Comparator group

Description:

Solvent detergent FFP

Treatment:

Other: plasma