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Clinical Trials/NCT05763446
NCT05763446
Recruiting
Not Applicable

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 sites in 1 country400 target enrollmentStarted: July 31, 2021Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
400
Locations
2
Primary Endpoint
Mortality

Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients undergoing liver transplantation

Exclusion Criteria

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

Outcomes

Primary Outcomes

Mortality

Time Frame: 90 days

90-day postoperative mortality after liver transplantation

Secondary Outcomes

  • In-hospital stay(Days until discharge from the hospital, an average of 14 days)
  • Post-transplant complication(90 days)
  • Postoperative mechanical ventilation(48 hours)
  • Intensive care unit stay(Days until discharge from ICU, an average of 5 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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