CClinicalTrials.gg
RecruitingNCT05763446TRADIFEGUpdated Mar 10, 2023

Predictive Factors for Massive Transfusion During Liver Transplantation

An observational study in Liver Transplant; Complications, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-10.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Started Jul 2021; still recruiting 5 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Liver Transplant; Complications

Keywords

  • Transfusions
  • Mortality
03

In context

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients undergoing liver transplantation.

Inclusion criteria

  • Patients undergoing liver transplantation

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years
  • Retransplantation within 30 days
  • Combined kidney-liver transplantation
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
400 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Mortality

    90-day postoperative mortality after liver transplantation

    Time frame: 90 days

Secondary outcomes

  1. Postoperative mechanical ventilation

    Duration of invasive mechanical ventilation

    Time frame: 48 hours

  2. Intensive care unit stay

    Duration of intensive care unit stay

    Time frame: Days until discharge from ICU, an average of 5 days

  3. In-hospital stay

    Hospital stay duration after liver transplant

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

  4. Post-transplant complication

    90-day postoperative complications after liver transplantation

    Time frame: 90 days

07

Study locations

2 of 2 sites recruiting
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05763446
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
Mar 10, 2023
Start date
Jul 31, 2021
Primary completion
Jul 31, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Mar 10, 2023

Study contacts

Paola Aceto, MD
Contact
paola.aceto@policlinicogemelli.it
+390630154507
Paola Aceto, MD
principal investigator · Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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