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

Early Phase 1

Withdrawn

• Conditions: Transfusion Related Complication; Liver Transplant
• Interventions: Biological: Donor Blood; Biological: Banked Blood

• Registration Number: NCT04383756
• Lead Sponsor: Vanderbilt University Medical Center

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-12
• Study Start: 2020-12
• Primary Completion: 2021-07
• Study Completion: 2021-07
• Last Update Submitted: 2022-02-21
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Donor Blood	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
Banked 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

Primary Outcome Measures

Name	Time	Method
Economic cost	perioperative up to 72 hours post operative	Total cost of perioperative transfusions
Use of allogenic banked blood products	perioperative up to 72 hours post operative	Measured by the number of allogenic banked blood products used

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States