Predictive Factors for Massive Transfusion During Liver Transplantation

NCT05763446 | Recruiting

• 1 other identifier: 4216
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Liver Transplant; Complications

Keywords

Transfusions; Mortality

Outcome Measures

Primary Outcomes (1)

• Mortality

  90-day postoperative mortality after liver transplantation

  90 days

Secondary Outcomes (4)

• Postoperative mechanical ventilation

  48 hours

• Intensive care unit stay

  Days until discharge from ICU, an average of 5 days

• In-hospital stay

  Days until discharge from the hospital, an average of 14 days

• Post-transplant complication

  90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing liver transplantation.

You may qualify if:

• Patients undergoing liver transplantation

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (2)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Study Officials

• Paola Aceto, MD

  Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Aceto, MD

CONTACT

+390630154507; paola.aceto@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: July 31, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 10, 2023

Record last verified: 2023-02

Locations

IT (2)