Predictive Factors for Massive Transfusion During Liver Transplantation (TRADIFEG)

February 28, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Predictive Factors for Massive Transfusion During Liver Transplantation: an Observational Study

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
      • Rome, Italy, 00168
        • Recruiting
        • UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Adult patients undergoing liver transplantation.

Description

Inclusion Criteria:

  • Patients undergoing liver transplantation

Exclusion Criteria:

  • Age <18 years
  • Retransplantation within 30 days
  • Combined kidney-liver transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days
90-day postoperative mortality after liver transplantation
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative mechanical ventilation
Time Frame: 48 hours
Duration of invasive mechanical ventilation
48 hours
Intensive care unit stay
Time Frame: Days until discharge from ICU, an average of 5 days
Duration of intensive care unit stay
Days until discharge from ICU, an average of 5 days
In-hospital stay
Time Frame: Days until discharge from the hospital, an average of 14 days
Hospital stay duration after liver transplant
Days until discharge from the hospital, an average of 14 days
Post-transplant complication
Time Frame: 90 days
90-day postoperative complications after liver transplantation
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2021

Primary Completion (Anticipated)

July 31, 2026

Study Completion (Anticipated)

October 31, 2026

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Estimate)

March 10, 2023

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4216

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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