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Predictive Factors for Massive Transfusion During Liver Transplantation (TRADIFEG)

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ClinicalTrials.gov Identifier: NCT05763446
Recruitment Status : Recruiting
First Posted : March 10, 2023
Last Update Posted : March 10, 2023
Sponsor:
Information provided by (Responsible Party):
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Tracking Information
First Submitted Date February 28, 2023
First Posted Date March 10, 2023
Last Update Posted Date March 10, 2023
Actual Study Start Date July 31, 2021
Estimated Primary Completion Date July 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2023)		 Mortality [ Time Frame: 90 days ]
90-day postoperative mortality after liver transplantation
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 28, 2023)
  • Postoperative mechanical ventilation [ Time Frame: 48 hours ]
    Duration of invasive mechanical ventilation
  • Intensive care unit stay [ Time Frame: Days until discharge from ICU, an average of 5 days ]
    Duration of intensive care unit stay
  • In-hospital stay [ Time Frame: Days until discharge from the hospital, an average of 14 days ]
    Hospital stay duration after liver transplant
  • Post-transplant complication [ Time Frame: 90 days ]
    90-day postoperative complications after liver transplantation
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predictive Factors for Massive Transfusion During Liver Transplantation
Official Title Predictive Factors for Massive Transfusion During Liver Transplantation: an Observational Study
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients undergoing liver transplantation.
Condition Liver Transplant; Complications
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 28, 2023)		 400
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2026
Estimated Primary Completion Date July 31, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients undergoing liver transplantation

Exclusion Criteria:

  • Age <18 years
  • Retransplantation within 30 days
  • Combined kidney-liver transplantation
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Paola Aceto, MD +390630154507 paola.aceto@policlinicogemelli.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT05763446
Other Study ID Numbers 4216
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Original Responsible Party Same as current
Current Study Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Paola Aceto, MD Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
PRS Account Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Verification Date February 2023