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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2021

Interventions

  • Biological: Donor Blood
    • Up to 4 units (each unit contains 350mL) of leukoreduced donor whole blood
  • Biological: Banked Blood
    • Up to 350mL of Allogenic banked component blood transfusion in a 1:1:1 manner (packed red blood cells : plasma : platelets)

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Economic cost
    • Time Frame: perioperative up to 72 hours post operative
    • Total cost of perioperative transfusions

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Clayne Benson, Assistant Professor, Department of Cardiothoracic Anesthesia and Critical Care – Vanderbilt University Medical Center
  • Overall Official(s)
    • Clayne Benson, MD, Principal Investigator, Vanderbilt University Medical Center
  • Overall Contact(s)
    • Clayne Benson, MD, 615-343-6268, clayne.benson@vumc.org

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