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NCT Number: NCT05763446

Predictive Factors for Massive Transfusion During Liver Transplantation

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing liver transplantation

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 90 days

    90-day postoperative mortality after liver transplantation

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Paola Aceto, MD

CONTACT

[email protected]

+390630154507

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: TRADIFEG

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2023
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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