Donor to Recipient Gender Mismatch in LDLTNCT04068363
Donor Gender Effect on Graft Function in Adult Egyptian Patients Undergoing Living Donor Liver Transplant
An observational study of Donor to Recipient Gender Mismatch in LDLT, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Donor to Recipient Gender Mismatch in LDLT
- What is being tested?
- non interventional
- How many people
- 342 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2019to 20 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult Egyptian Patients >18 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- non interventional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non interventionalOther
non interventional study
| Study group | Role | What they receive |
|---|---|---|
| Matched group | Same sex of both donor and recipient Receives: Other: non interventional | |
| Mismatched group | Sex mismatch between donor and recipient, subgroups might be added Receives: Other: non interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 years survival post liver transplant.
The primary outcome will be survival at 2 years post liver transplant
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start15 Aug 2019
- Primary completion15 Mar 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Donor to Recipient Gender Mismatch in LDLTStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Mohamed Abdallah ElGendy MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068363
- Sponsor's protocol ID
- IBR/0006379
- Status last verified
- Feb 2022
- First submitted
- 20 Aug 2019
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donor Gender Effect on Graft Function in Adult Egyptian Patients Undergoing Living Donor Liver Transplant: A Single Centre Retrospective Study
- ClinicalTrials.gov ID
- NCT04068363
- Acronym / sponsor ID
- IBR/0006379
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matched group | – | Other: non interventionalSame sex of both donor and recipient |
| Mismatched group | – | Other: non interventionalSex mismatch between donor and recipient, subgroups might be added |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult Egyptian Patients >18 years.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non interventionalnon interventional study | Other | Matched group, Mismatched group |
Primary outcome
2 years survival post liver transplant.
Time frame: 3 months
The primary outcome will be survival at 2 years post liver transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Donor to Recipient Gender Mismatch in LDLT, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 years survival post liver transplant. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.