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

NCT04068363 | Completed

• 1 other identifier: IBR/0006379
• Study Type: observational
• Target: 342
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Donor to Recipient Gender Mismatch in LDLT

Outcome Measures

Primary Outcomes (1)

• 2 years survival post liver transplant.

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

  3 months

Study Arms (2)

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

non interventional OTHER

non interventional study

Matched group; Mismatched group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult Egyptian Patients \>18 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 28, 2019
• Study Start: August 15, 2019
• Primary Completion: March 15, 2021
• Study Completion: June 20, 2021
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)