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NCT02767622 Clinical Trial

Reversibility of Minimal Hepatic Encephalopathy Following Liver Transplantation

Minimal Hepatic Encephalopathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02767622
Other study ID # 875
Secondary ID
Status Completed
Phase N/A
First received May 7, 2016
Last updated May 9, 2016
Start date June 2014

Study information
Verified date May 2016
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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).

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Liver transplantation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement of Psychometric tests. 6 months following liver transplantation. Yes
Secondary Improvement of liver functions and MELD score following liver transplantation. 6 months following liver transplantation. Yes
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