Utilization of Donor Whole Blood for Blood Transfusion in Deceased Donor Liver Transplantation

Vanderbilt University Medical Center

Status and phase: Withdrawn; Early Phase 1

Conditions: Transfusion Related Complication; Liver Transplant

Treatments: Biological: Donor Blood; Biological: Banked Blood

Study type: Interventional

Funder types: Other

Identifiers

NCT04383756

UDWBBT

Details and patient eligibility

About

We will study 40 matched patients. 20 patients will receive leukoreduced whole blood from the solid organ donor. These 20 patients will be compared to 20 historical matched controls with regards to allogenic blood product usage and other physiologic markers

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Recipients 18 years or older.
• Deceased donor whole graft liver transplant recipients undergoing liver transplant starting 07/01/2020 and onwards at VUMC.
• ABO-matched recipient and donor.
• Donor Hb level >/= 8 g/dL
• Recipients with negative ABO antibody screen

Exclusion criteria

• • Pediatric recipient.
• HBS Antigen+ donors
• HCV NAT+ donors
• Donors of A2 blood type
• Donors on oral anticoagulants (except for aspirin) over the past 3 days before organ procurement

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Donor Blood

Experimental group

Description:

Between 2-4 units of donor leukoreduced whole blood (each unit will contain up to 350mL) transfused as needed in Liver transplantation participants

Treatment:

Biological: Donor Blood

Banked Blood

Active Comparator group

Description:

Standard of Care - Up to 350mL Allogenic banked component blood transfusion in a 1:1:1 manner (packed red blood cells : plasma : platelets) transfused as needed in Liver transplantation participants

Treatment:

Biological: Banked Blood