NCT02767622

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

10 months

First QC Date

May 7, 2016

Last Update Submit

May 9, 2016

Conditions

Minimal Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

  • Improvement of Psychometric tests.

    6 months following liver transplantation.

Secondary Outcomes (1)

  • Improvement of liver functions and MELD score following liver transplantation.

    6 months following liver transplantation.

Study Arms (2)

Patient Group

Twenty right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation.

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.

Interventions

Liver transplantationPROCEDURE
Patient Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Twenty right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation.

You may qualify if:

  • Right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Liver Transplantation

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 7, 2016

First Posted

May 10, 2016

Study Start

June 1, 2014

Primary Completion

April 1, 2015

Last Updated

May 11, 2016

Record last verified: 2016-05