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CompletedNCT04068363Updated Feb 16, 2022

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

An observational study in Donor to Recipient Gender Mismatch in LDLT, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-16.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
342
Ages
18 Years and older
Sex
All
01

Study summary

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

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Conditions studied

  • Donor to Recipient Gender Mismatch in LDLT
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Adult Egyptian Patients >18 years.

Exclusion criteria

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.
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
342 participants (actual)
Patient registry
No

Groups and cohorts

  • Matched group

    Same sex of both donor and recipient

    Other: non interventional

  • Mismatched group

    Sex mismatch between donor and recipient, subgroups might be added

    Other: non interventional

Interventions

  • Othernon interventional

    non interventional study

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What researchers measure

Primary outcomes

  1. 2 years survival post liver transplant.

    The primary outcome will be survival at 2 years post liver transplant

    Time frame: 3 months

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Study locations

1 site
  • Hanaa El Gendy
    Cairo, Ain Shams University Specialized Hospital, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04068363
Lead sponsor
Ain Shams University
Responsible party
Hanaa Mohamed Abdallah ElGendy MD (Assistant Professor, Ain Shams University) — Principal investigator
First posted
Aug 28, 2019
Start date
Aug 15, 2019
Primary completion
Mar 15, 2021
Completion
Jun 20, 2021
Last update
Feb 16, 2022

Oversight

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

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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