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

February 21, 2022 updated by: Vanderbilt University Medical Center
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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Biological: Donor Blood
Up to 4 units (each unit contains 350mL) of leukoreduced donor whole blood
Active Comparator: 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
Biological: Banked Blood
Up to 350mL of Allogenic banked component blood transfusion in a 1:1:1 manner (packed red blood cells : plasma : platelets)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Clayne Benson, MD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

February 21, 2022

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDWBBT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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