Predictive Factors for Massive Transfusion During Liver Transplantation

Liver Transplant; Complications Clinical Trial

— TRADIFEG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763446
• Other study ID #: 4216
• Status: Recruiting
• Start date: July 31, 2021
• Est. completion date: October 31, 2026

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Paola Aceto, MD
• Phone: +390630154507
• Email: paola.aceto[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing liver transplantation

Exclusion Criteria:

• Age <18 years

• Retransplantation within 30 days

• Combined kidney-liver transplantation

Related Conditions & MeSH terms

• Liver Transplant; Complications

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome
Italy	UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	90-day postoperative mortality after liver transplantation	90 days
Secondary	Postoperative mechanical ventilation	Duration of invasive mechanical ventilation	48 hours
Secondary	Intensive care unit stay	Duration of intensive care unit stay	Days until discharge from ICU, an average of 5 days
Secondary	In-hospital stay	Hospital stay duration after liver transplant	Days until discharge from the hospital, an average of 14 days
Secondary	Post-transplant complication	90-day postoperative complications after liver transplantation	90 days