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

Study Overview
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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

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

Conditions
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Transfusion Related Complication, Liver Transplant

Intervention / Treatment
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* Biological: Donor Blood
* Biological: Banked Blood


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 20 recipients receive donor whole blood 20 historic match controls are compared to the 20 study participants
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of allogenic banked blood products | Measured by the number of allogenic banked blood products used | perioperative up to 72 hours post operative | 
| Economic cost | 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) | Number of deaths, life-threatening events, hospitalizations, disabilities or permanent damage, or congenital anomalies | Baseline to discharge (approximately 4-5 days) |