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

Liver Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04383756
• Other study ID #: UDWBBT
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: December 2020
• Est. completion date: July 2021

Study information

• Verified date: May 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Liver Transplant
• Transfusion Related Complication

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of allogenic banked blood products	Measured by the number of allogenic banked blood products used	perioperative up to 72 hours post operative
Primary	Economic cost	Total cost of perioperative transfusions	perioperative up to 72 hours post operative
Secondary	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)