Donors SafetyNCT01809249
Causes of Disqualification of Egyptian Potential Living Liver Donors
An observational study of Donors Safety, run by Ain Shams University at 1 site in Egypt.
Trial summary
Due to absence of Deceased-donors in Egypt, Living-donor liver transplantation (LDLT) has emerged as an option to the traditional deceased-donor transplantation procedure. But there is an essential risk related to liver resection for healthy donors. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Donors Safety
- How many people
- 192 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2010to Jun 2012
- How long will I take part?
- 3 Months
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: potential living liver donors
Who may be able to join
- All potential living liver donors in the period from June 2010 to June 2012
- Age between 18 and 50 years
- Relationship within 3rd degree of consanguinity with recipient or spouse.
- The donor-recipient pair must be blood group compatible.
- An informed consent should be obtained.
Who cannot join
- Patients with nknown mrsdical or surgical history that interfere with donation
- Underlying medical condition (diabetes, cardiopulmonary disease, etc.).
- ABO incompatibility
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams Center For Organ Transplantation (ASCOT),Ain Shams university
Cairo
About this study
Due to absence of Deceased-donors in Egypt, Living-donor liver transplantation (LDLT) has emerged as an option to the traditional deceased-donor transplantation procedure. But there is an essential risk related to liver resection for healthy donors.
Read the detailed description
The aim of this work is to identify and analyze the causes of disqualification of potential Egyptian living liver-donors in a University based liver transplant program
- Conditions
- Donors Safety
- Keywords
- Living donor liver transplantation, Donar safety
What is being measured
The primary outcome is the main question the study is designed to answer.
causes of disqualification of potential Egyptian living liver-donors
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Donors SafetyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iman Fawzy Montasser, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809249
- Sponsor's protocol ID
- Donar Safety
- Status last verified
- Mar 2013
- First submitted
- 9 Mar 2013
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes of Disqualification of Egyptian Potential Living Liver Donors
- ClinicalTrials.gov ID
- NCT01809249
- Acronym / sponsor ID
- Donar Safety
- Conditions
- Donors Safety
- Keywords
- Living donor liver transplantation, Donar safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Mar 2013 (estimated)
- 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.
Due to absence of Deceased-donors in Egypt, Living-donor liver transplantation (LDLT) has emerged as an option to the traditional deceased-donor transplantation procedure. But there is an essential risk related to liver resection for healthy donors.
Detailed description
The aim of this work is to identify and analyze the causes of disqualification of potential Egyptian living liver-donors in a University based liver transplant program
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- potential living liver donors
Key inclusion criteria (5 listed)
- All potential living liver donors in the period from June 2010 to June 2012
Key exclusion criteria (3 listed)
- Patients with nknown mrsdical or surgical history that interfere with donation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
causes of disqualification of potential Egyptian living liver-donors
Time frame: 2 years
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 12 Mar 2013.
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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 Donors Safety, 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 5 inclusion and 3 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 12 Mar 2013. 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?
causes of disqualification of potential Egyptian living liver-donors (time frame: 2 years). 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 12 Mar 2013.