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Predictive Factors for Massive Transfusion During Liver Transplantation (TRADIFEG)

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ClinicalTrials.gov Identifier: NCT05763446
Recruitment Status : Recruiting
First Posted : March 10, 2023
Last Update Posted : March 10, 2023
Sponsor:
Information provided by (Responsible Party):
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Description
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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
Liver Transplant; Complications

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
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Study Type : Observational
Estimated 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 : July 31, 2021
Estimated Primary Completion Date : July 31, 2026
Estimated Study Completion Date : October 31, 2026

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Mortality [ Time Frame: 90 days ]
    90-day postoperative mortality after liver transplantation


Secondary Outcome Measures :
  1. Postoperative mechanical ventilation [ Time Frame: 48 hours ]
    Duration of invasive mechanical ventilation

  2. Intensive care unit stay [ Time Frame: Days until discharge from ICU, an average of 5 days ]
    Duration of intensive care unit stay

  3. In-hospital stay [ Time Frame: Days until discharge from the hospital, an average of 14 days ]
    Hospital stay duration after liver transplant

  4. Post-transplant complication [ Time Frame: 90 days ]
    90-day postoperative complications after liver transplantation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing liver transplantation.
Criteria

Inclusion Criteria:

  • Patients undergoing liver transplantation

Exclusion Criteria:

  • Age <18 years
  • Retransplantation within 30 days
  • Combined kidney-liver transplantation
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05763446


Contacts
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Contact: Paola Aceto, MD +390630154507 paola.aceto@policlinicogemelli.it

Locations
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Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS Recruiting
Rome, Italy, 00168
UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS Recruiting
Rome, Italy, 00168
Contact: Paola Aceto, MD    00390630154507    paola.aceto@policlinicogemelli.it   
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
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Principal Investigator: Paola Aceto, MD Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
More Information
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Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT05763446    
Other Study ID Numbers: 4216
First Posted: March 10, 2023    Key Record Dates
Last Update Posted: March 10, 2023
Last Verified: February 2023

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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:
Transfusions
Mortality