TRADIFEG: Predictive Factors for Massive Transfusion During Liver Transplantation

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05763446
Collaborator
(none)
400
2
63
200
3.2

Study Details

Study Description

Brief Summary

Liver transplantation (LT) is the treatment of choice for patients with end-stage liver disease (1). LT is often associated with severe intraoperative blood loss and the literature has had a great interest in clarifying the predictive factors for transfusion requirements during this surgery. Despite the advances in surgical techniques, graft preservation, and anesthetic management achieved over the past two decades, intraoperative bleeding and blood component consumption during LT are still issues of current interest. The requirement for blood components is highly variable between different transplant centers and ranges from none to many units of red blood cells (RBC), plasma, and platelets per patient. Bleeding associated with LT is multifactorial. Among the pre-transplantation factors, portal hypertension and coagulation defects are of great importance. The latter can develop or amplify during the anaepatic and/or neohepatic phase due to the absence of hepatic metabolic function, hyperfibrinolysis or platelet sequestration in the graft. In the literature, the higher transfusion requirement (HTR) is associated with worse postoperative outcomes, with an increase in both the length of stay in the intensive care unit (ICU) and in hospital, and mortality.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of this study is to evaluate the influence of increased transfusion requirements on the prognosis of patients undergoing LT and the risk factors for HTR. HTR is defined as the consumption of packed red blood cells (GRC) ≥ 5 units in the first 24 hours of surgery.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Predictive Factors for Massive Transfusion During Liver Transplantation: an Observational Study
    Actual Study Start Date :
    Jul 31, 2021
    Anticipated Primary Completion Date :
    Jul 31, 2026
    Anticipated Study Completion Date :
    Oct 31, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [90 days]

      90-day postoperative mortality after liver transplantation

    Secondary Outcome Measures

    1. Postoperative mechanical ventilation [48 hours]

      Duration of invasive mechanical ventilation

    2. Intensive care unit stay [Days until discharge from ICU, an average of 5 days]

      Duration of intensive care unit stay

    3. In-hospital stay [Days until discharge from the hospital, an average of 14 days]

      Hospital stay duration after liver transplant

    4. Post-transplant complication [90 days]

      90-day postoperative complications after liver transplantation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing liver transplantation
    Exclusion Criteria:
    • Age <18 years

    • Retransplantation within 30 days

    • Combined kidney-liver transplantation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy 00168
    2 UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy 00168

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    • Principal Investigator: Paola Aceto, MD, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT05763446
    Other Study ID Numbers:
    • 4216
    First Posted:
    Mar 10, 2023
    Last Update Posted:
    Mar 10, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Study Results

    No Results Posted as of Mar 10, 2023