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

NCT ID: NCT04383756

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-31

Study Completion Date

2021-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Transfusion Related Complication Liver Transplant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Donor Blood

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

Group Type EXPERIMENTAL

Donor Blood

Intervention Type BIOLOGICAL

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

Banked Blood

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

Group Type ACTIVE_COMPARATOR

Banked Blood

Intervention Type BIOLOGICAL

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

Interventions

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Donor Blood

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

Intervention Type BIOLOGICAL

Banked Blood

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clayne Benson, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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UDWBBT

Identifier Type: -

Identifier Source: org_study_id

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