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

NCT04383756 | Withdrawn Early Phase 1

• 1 other identifier: UDWBBT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Transfusion Related Complication; Liver Transplant

Outcome Measures

Primary Outcomes (2)

• Use of allogenic banked blood products

  Measured by the number of allogenic banked blood products used

  perioperative up to 72 hours post operative

• Economic cost

  Total cost of perioperative transfusions

  perioperative up to 72 hours post operative

Secondary Outcomes (1)

• Number of Serious Adverse Events (SAEs)

  Baseline to discharge (approximately 4-5 days)

Study Arms (2)

Donor Blood

EXPERIMENTAL

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

Biological: Donor Blood

Banked Blood

ACTIVE COMPARATOR

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

Biological: Banked Blood

Interventions

Donor Blood BIOLOGICAL

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

Donor Blood

Banked Blood BIOLOGICAL

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

Banked Blood

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37205, United States

Location

Study Officials

• Clayne Benson, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: December 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: March 9, 2022

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)