Clinical trial NCT05763446: Predictive Factors for Massive Transfusion During Liver Transplantation
Official title: Predictive Factors for Massive Transfusion During Liver Transplantation: an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Transplant; Complications
Keywords: Transfusions
Mortality
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing liver transplantation.

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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing liver transplantation

Exclusion Criteria:

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

Primary outcomes:
measure: Mortality
timeFrame: 90 days
Secondary outcomes:
measure: Postoperative mechanical ventilation
timeFrame: 48 hours
measure: Intensive care unit stay
timeFrame: Days until discharge from ICU, an average of 5 days
measure: In-hospital stay
timeFrame: Days until discharge from the hospital, an average of 14 days
measure: Post-transplant complication
timeFrame: 90 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
city: Rome
country: Italy
facility: UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
name: Paola Aceto, MD
role: PRINCIPAL_INVESTIGATOR
References: