Controlled Donors After Circulatory Death and Brain Death: a Multicenter Study of Transfusion, One-year Graft Survival and Mortality. Cohort Study,

Controlled Donors After Circulatory Death and Brain Death: a Multicenter Study of

RBC requirement ein DBD and DCD liver transplants

Study Overview

• Status: Completed
• Conditions: Liver Transplant

Detailed Description

Background: Controlled donation after cardiac circulatory death (cDCD) is accepted to expand the donor pool for liver transplantation (LT). However, transfusion requirements and perioperative outcomes should be elucidated. The aims of this multicentre study are to assess the red blood cell (RBC) transfusions, one-year graft and patient survival after LT with cDCD compared to donors after brain dead (DBD).

Methods: 591 LT patients conducted in ten centers during 2019 were reviewed. Thromboelastometry was used to manage coagulation and blood product transfusion in all centres. Normothermic regional perfusion was the standard technique for organ recovery.

• Study Type: Observational
• Enrollment (Actual): 591

Contacts and Locations

Study Locations

• Spain
  • Bilbao, Spain
    • Hospital de Cruces
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain
      • Hospital Universitari de Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing LT

Description

Inclusion Criteria:

• patients undergoing LT

Exclusion Criteria:

• acute liver failure

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
liver donors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
RBC transfusion	intraoperative

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): June 25, 2021

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Death; Unconsciousness; Consciousness Disorders; Coma; Brain Death
• Other Study ID Numbers: HCB/2019/1160

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