Liver TransplanatationRIRINCT02534025
Remote Ischemic Preconditioning in Liver Transplantation
A study testing Ischemia preconditioining in people with Liver Transplanatation, run by Mansoura University at 1 site in Egypt.
Trial summary
Remote (upper arm) ischemic preconditioning in the donor of living donor liver transplanta to ameliorate the effect of reperfusion injury in recipients. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Liver Transplanatation
- What is being tested?
- Ischemia preconditioining
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Mar 2017
- Phase
- Interventional
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All candidates for living donor liver transplantation
Who cannot join
- Donors with peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
Amr Yassen, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Mansoura university
Al Mansurah, Dkahleya
Alreafey Kandeel, MD, 00201008158591, refa3ey2@yahoo.com
About this study
Remote (upper arm) ischemic preconditioning in the donor of living donor liver transplanta to ameliorate the effect of reperfusion injury in recipients.
Read the detailed description
Upper arm ischemia will be induced by elevation of NIBP cuff pressure to 200 mm Hg for 5 minutes repeated four times 5 mniutes apart, aiming to decrease the effect of ischemia reperfusion in the graft liver.
- Conditions
- Liver Transplanatation
- Being tested
- Ischemia preconditioining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemia preconditioiningProcedure or surgery
Elavate blood pressure cuff pressure to 200
| Study group | Role | What they receive |
|---|---|---|
| P group | Experimental | Elevation of Cuff pressure to 200 mm Hg for 5 minutes four times 5 minutes apart Receives: Procedure: Ischemia preconditioining |
| C group | No intervention | no intervention will be added to routine anesthetic mangement |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver enzymes ( SGOT and SGPT) as indicator of graft injury
Hemodynamic effects of reperfusion ijury
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startJan 2016
- Primary completionFeb 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplanatationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AlRefaey Kandeel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534025
- Sponsor's protocol ID
- 1/2015
- Acronym
- RIRI
- Status last verified
- Feb 2017
- First submitted
- 9 Aug 2015
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning in Liver Transplantation
- ClinicalTrials.gov ID
- NCT02534025
- Acronym / sponsor ID
- RIRI / 1/2015
- Conditions
- Liver Transplanatation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 27 Aug 2015 (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.
Remote (upper arm) ischemic preconditioning in the donor of living donor liver transplanta to ameliorate the effect of reperfusion injury in recipients.
Detailed description
Upper arm ischemia will be induced by elevation of NIBP cuff pressure to 200 mm Hg for 5 minutes repeated four times 5 mniutes apart, aiming to decrease the effect of ischemia reperfusion in the graft liver.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P group | Experimental | Procedure: Ischemia preconditioiningElevation of Cuff pressure to 200 mm Hg for 5 minutes four times 5 minutes apart |
| C group | No intervention | –no intervention will be added to routine anesthetic mangement |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All candidates for living donor liver transplantation
Key exclusion criteria (1 listed)
- Donors with peripheral vascular disease
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 |
|---|---|---|
| Ischemia preconditioiningElavate blood pressure cuff pressure to 200 | Procedure or surgery | P group |
Primary outcome
liver enzymes ( SGOT and SGPT) as indicator of graft injury
Time frame: 30 minutes
Hemodynamic effects of reperfusion ijury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
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.
Amr Yassen, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemia preconditioining in people with Liver Transplanatation, run by Mansoura 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 1 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: status not confirmed, as of the sponsor's last update on 7 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AlRefaey Kandeel, MD (+201008158591, refa3ey2@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver enzymes ( SGOT and SGPT) as indicator of graft injury (time frame: 30 minutes). 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 7 Feb 2017.