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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068363
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Hanaa Mohamed Abdallah ElGendy MD, Ain Shams University

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

Condition or disease Intervention/treatment
Donor to Recipient Gender Mismatch in LDLT Other: non interventional

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Donor Gender Effect on Graft Function in Adult Egyptian Patients Undergoing Living Donor Liver Transplant: A Single Centre Retrospective Study
Actual Study Start Date : August 15, 2019
Actual Primary Completion Date : February 15, 2020
Estimated Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 2 years survival post liver transplant. [ Time Frame: 3 months ]
    The primary outcome will be survival at 2 years post liver transplant



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068363


Contacts
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Contact: Hanaa A ELGENDY +201001029544 hanaa.elgendy@yahoo.com

Locations
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Egypt
Hanaa El Gendy Recruiting
Cairo, Ain Shams University Specialized Hospital, Egypt
Contact: Hanaa Abdalla ElGendy    0100 102 9544    Hanaa.elgendy@yahoo.com   
Sponsors and Collaborators
Ain Shams University
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Responsible Party: Hanaa Mohamed Abdallah ElGendy MD, Assistant Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT04068363    
Other Study ID Numbers: IBR/0006379
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No