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

Primary Purpose

Transfusion Related Complication, Liver Transplant

Status

Withdrawn

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Donor Blood

Banked Blood

About this trial

This is an interventional treatment trial for Transfusion Related Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Donor Blood

Banked Blood

Arm Description

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

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

Outcomes

Primary Outcome Measures

Use of allogenic banked blood products

Measured by the number of allogenic banked blood products used

Economic cost

Total cost of perioperative transfusions

Secondary Outcome Measures

Number of Serious Adverse Events (SAEs)

Number of deaths, life-threatening events, hospitalizations, disabilities or permanent damage, or congenital anomalies

Full Information

NCT ID

NCT04383756

First Posted

May 7, 2020

Last Updated

February 21, 2022

Sponsor

Vanderbilt University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04383756

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Study was never started

Study Start Date

December 2020 (Anticipated)

Primary Completion Date

July 2021 (Anticipated)

Study Completion Date

July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Transfusion Related Complication, Liver Transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Donor Blood

Arm Type

Experimental

Arm Description

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

Arm Title

Banked Blood

Arm Type

Active Comparator

Arm 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

Intervention Type

Biological

Intervention Name(s)

Donor Blood

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Banked Blood

Intervention Description

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

Primary Outcome Measure Information:

Title

Use of allogenic banked blood products

Description

Measured by the number of allogenic banked blood products used

Time Frame

perioperative up to 72 hours post operative

Title

Economic cost

Description

Total cost of perioperative transfusions

Time Frame

perioperative up to 72 hours post operative

Secondary Outcome Measure Information:

Title

Number of Serious Adverse Events (SAEs)

Description

Number of deaths, life-threatening events, hospitalizations, disabilities or permanent damage, or congenital anomalies

Time Frame

Baseline to discharge (approximately 4-5 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clayne Benson, MD

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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