Predictive Factors for Massive Transfusion During Liver Transplantation

Recruiting

• Conditions: Liver Transplant; Complications

• Registration Number: NCT05763446
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

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 Timeline

• Study Start: 2021-07-31
• Status Verified: 2023-02
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Study First Posted: 2023-03-10
• Last Update Posted: 2023-03-10
• Primary Completion: 2026-07-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients undergoing liver transplantation

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	90 days	90-day postoperative mortality after liver transplantation

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, Italy

UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, Italy