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Predictive Factors for Massive Transfusion During Liver Transplantation

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05763446
Acronym
TRADIFEG
Enrollment
400
Registered
2023-03-10
Start date
2021-07-31
Completion date
2026-10-31
Last updated
2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant; Complications

Keywords

Transfusions, Mortality

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.

Interventions

None listed

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing liver transplantation

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality90 days90-day postoperative mortality after liver transplantation

Secondary

MeasureTime frameDescription
Postoperative mechanical ventilation48 hoursDuration of invasive mechanical ventilation
Intensive care unit stayDays until discharge from ICU, an average of 5 daysDuration of intensive care unit stay
In-hospital stayDays until discharge from the hospital, an average of 14 daysHospital stay duration after liver transplant
Post-transplant complication90 days90-day postoperative complications after liver transplantation

Countries

Italy

Contacts

Primary ContactPaola Aceto, MD
paola.aceto@policlinicogemelli.it+390630154507

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026