NCT Number: NCT02767622
Reversibility of Minimal Hepatic Encephalopathy Following Liver Transplantation
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.
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Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Observational
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation
Exclusion criteria
- 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).
Treatment and study plan
Primary outcomes
-
Improvement of Psychometric tests.
Time frame: 6 months following liver transplantation.
Secondary outcomes
-
Improvement of liver functions and MELD score following liver transplantation.
Time frame: 6 months following liver transplantation.
Sponsors and collaborators
Lead sponsor
Ain Shams University
Other
Registry information
Important dates
- Study start
- 2014
- Primary completion
- 2015
- First posted
- May 10, 2016
- Registry last updated
- May 11, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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