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

Status

Withdrawn

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04383756

Enrollment

Registered

2020-05-12

Start date

2020-12-31

Completion date

2021-07-31

Last updated

2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant, Transfusion Related Complication

Brief summary

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

Interventions

BIOLOGICALDonor Blood

Up to 4 units (each unit contains 350mL) of leukoreduced donor whole blood

BIOLOGICALBanked Blood

Up to 350mL of Allogenic banked component blood transfusion in a 1:1:1 manner (packed red blood cells : plasma : platelets)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

20 recipients receive donor whole blood 20 historic match controls are compared to the 20 study participants

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Use of allogenic banked blood products	perioperative up to 72 hours post operative	Measured by the number of allogenic banked blood products used
Economic cost	perioperative up to 72 hours post operative	Total cost of perioperative transfusions

Secondary

Measure	Time frame	Description
Number of Serious Adverse Events (SAEs)	Baseline to discharge (approximately 4-5 days)	Number of deaths, life-threatening events, hospitalizations, disabilities or permanent damage, or congenital anomalies

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026