Donor Gender Effect on Graft Function in Adult Egyptian Patients Undergoing Living Donor Liver Transplant

Donor Gender Effect on Graft Function in Adult Egyptian Patients Undergoing Living Donor Liver Transplant: A Single Centre Retrospective Study

Liver transplantation (LT) represents the gold-standard therapy for the treatment in case of dreadful liver pathologies . It is thus a main concern to optimize the results in terms of post-LT survivals. The effect of gender match on post-transplant outcome is still debatable. Hormonal , and size difference between female and male may be proposed to affect the post transplant outcome . The aim of this study is to evaluate the effect of donor-recipient gender mismatch on survival rates

Study Overview

• Status: Completed
• Conditions: Donor to Recipient Gender Mismatch in LDLT
• Intervention / Treatment: Other: non interventional

• Study Type: Observational
• Enrollment (Actual): 342

Contacts and Locations

Study Locations

• Egypt
  • Ain Shams University Specialized Hospital
    • Cairo, Ain Shams University Specialized Hospital, Egypt
      • Hanaa El Gendy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Intraoperatively, Both standard anesthetic and piggyback liver transplant for hepatic transplantation will be performed by the same anesthesia and surgical team . Intraoperative hemodynamics (MAP and HR), graft weight to recipient weight ratio (GWRWR), blood products transfused and intraoperative adverse events will be recorded. At the end of surgery patients will be transferred to the ICU where they will be monitored and will receive the standard protocol for postoperative management after liver transplantation.

- Recipients will be divided into two groups ( matched and mismatched) and will be subdivided based on the following variables: recipient age, MELD score, intraoperative packed red blood cells (PRBC) and fresh frozen plasma (FFP) transfusions, duration of cold ischemia. These subgroups will be compared with respect to 2-year graft survival separately in recipients of sex matched and mismatched transplantation.

Description

Inclusion Criteria:

• Adult Egyptian Patients >18 years.

Exclusion Criteria:

• Patient refusal.
• Patients who underwent re-transplantation before discharge from the ICU after the first liver transplant.
• Intraoperative cardiac arrest or immediately postoperative cardiac arrest within the first 6 hours postoperative.
• Massive blood loss.
• Pre-existing renal failure requiring hemodialysis or continuous hemofiltration.
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Matched group; Same sex of both donor and recipient	Other: non interventional; non interventional study
Mismatched group; Sex mismatch between donor and recipient, subgroups might be added	Other: non interventional; non interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2 years survival post liver transplant.	The primary outcome will be survival at 2 years post liver transplant	3 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): March 15, 2021
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IBR/0006379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No