Minimal Hepatic EncephalopathyNCT02767622
Reversibility of Minimal Hepatic Encephalopathy Following Liver Transplantation
An observational study of Minimal Hepatic Encephalopathy, run by Ain Shams University.
Trial summary
This study included 20 patients listed for liver transplantation in addition to 20 age- and sex- matched controls. Neurological, psychiatric, laboratory and radiological examinations were performed for both patients and controls before and 6 months after liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Minimal Hepatic Encephalopathy
- What is being tested?
- Liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Apr 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Twenty right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation.
Who may be able to join
- Right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation
Who cannot join
- Overt hepatic encephalopathy.
- Significant cortical atrophy or other structural brain changes revealed by conventional neuro-imaging.
- Regular use of psychotropic drugs, such as benzodiazepines.
- Known major psychiatric disorder.
- Less than 6 months of complete alcohol abstinence.
- Post-transplant toxic levels of immunosuppressive drugs.
- Patients unable to perform the tests (Illiterate or upper limb motor handicaps).
About this study
This study included 20 patients listed for liver transplantation in addition to 20 age- and sex- matched controls. Neurological, psychiatric, laboratory and radiological examinations were performed for both patients and controls before and 6 months after liver transplantation. Assessment of cognitive functions by Trail Making Test A (TMT A), TMT B, Digit Symbol Test (DST), and Serial Dotting Test (SDT) was done before and after liver transplantation.
- Conditions
- Minimal Hepatic Encephalopathy
- Being tested
- Liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | Twenty right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation. Receives: Procedure: Liver transplantation | |
| Control Group | Twenty age-matched healthy persons. They were similar to the patient group in respect to the number of education years, sex, and handedness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Psychometric tests.
Measured: 6 months following liver transplantation.
Secondary outcomes (1)
Improvement of liver functions and MELD score following liver transplantation.
Measured: 6 months following liver transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startJun 2014
- Primary completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Hepatic EncephalopathyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdelhakam, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767622
- Sponsor's protocol ID
- 875
- Status last verified
- May 2016
- First submitted
- 7 May 2016
- Last updated
- 11 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversibility of Minimal Hepatic Encephalopathy Following Liver Transplantation
- ClinicalTrials.gov ID
- NCT02767622
- Acronym / sponsor ID
- 875
- Conditions
- Minimal Hepatic Encephalopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- First posted
- 10 May 2016 (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.
This study included 20 patients listed for liver transplantation in addition to 20 age- and sex- matched controls. Neurological, psychiatric, laboratory and radiological examinations were performed for both patients and controls before and 6 months after liver transplantation. Assessment of cognitive functions by Trail Making Test A (TMT A), TMT B, Digit Symbol Test (DST), and Serial Dotting Test (SDT) was done before and after liver transplantation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Group | – | Procedure: Liver transplantationTwenty right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation. |
| Control Group | – | –Twenty age-matched healthy persons. They were similar to the patient group in respect to the number of education years, sex, and handedness. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Twenty right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation.
Key inclusion criteria (1 listed)
- Right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation
Key exclusion criteria (7 listed)
- Overt hepatic encephalopathy.
- Significant cortical atrophy or other structural brain changes revealed by conventional neuro-imaging.
- Regular use of psychotropic drugs, such as benzodiazepines.
- Known major psychiatric disorder.
- Less than 6 months of complete alcohol abstinence.
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 |
|---|---|---|
| Liver transplantation | Procedure or surgery | Patient Group |
Primary outcome
Improvement of Psychometric tests.
Time frame: 6 months following liver transplantation.
1 secondary outcome
Improvement of liver functions and MELD score following liver transplantation.
Time frame: 6 months following liver transplantation.
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 11 May 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Minimal Hepatic Encephalopathy, run by Ain Shams University.
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 7 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 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Improvement of Psychometric tests. (time frame: 6 months following liver transplantation.). 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 11 May 2016.