Minimal HePatic Encephalopathy Among CiRrhotics. A Cross SEctional, Clinico-EpidEmiological, Multi-Centre, Study in Patients of PakisTan
Preempt
1 other identifier
observational
550
1 country
6
Brief Summary
The Preempt study is likely to help determine the frequency of patients suffering from Minimal Hepatic Encephalopathy (MHE) and are cirrhotics. It will also enable us to know about the Quality of life of these patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 6, 2015
CompletedFirst Posted
Study publicly available on registry
November 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedMay 11, 2017
May 1, 2017
1.3 years
November 6, 2015
May 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of MHE in Cirrhotic patients
Continuous variables with normal and non-normal distributions would be reported as mean (SD) and median \[inter-quartile range (IQR)\], respectively. Prevalence of MHE in cirrhotic patients with 95% confidence Interval (CI) will be calculated. Continuous variables between group will compared by using Independent sample t test, and categorical variables will compare by using the chi-square test.
18 months
Secondary Outcomes (3)
The predisposing factors that might be associated with MHE in all enrolled patients with cirrhosis
18 months
Quality of Life (QoL) of patients at baselines
18 months
Management of MHE currently in practice
18 months
Eligibility Criteria
Primary Care Clinic/Private Clinic
You may qualify if:
- Patients of either sex, 18-65 years of age, who have attended school at least till the 5th Class/Standard having an established diagnosis of liver cirrhosis without any overt symptoms at time of testing with Grade 0 of West Haven criteria.
- Patients willing to undergo the neuropsychological (NP) tests and to complete the SF-36 questionnaire for the estimation of Health Related Quality of Life (HRQOL).
- Patients willing to provide written authorization to provide data for the study.
You may not qualify if:
- Patients with inability to perform neuropsychometric tests and to complete the SF-36 questionnaire as decided by the physician.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
- Dimension Researchcollaborator
Study Sites (6)
Baqai Hospital
Karachi, 74700, Pakistan
Fatima Memorial Hospital
Lahore, 54000, Pakistan
Lahore General Hospital
Lahore, 54000, Pakistan
Jinnah Hospital Lahore
Lahore, 54550, Pakistan
Doctor's Hospital
Lahore, 54770, Pakistan
Lady Reading Hospital
Peshawar, 25000, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Raeefuddin Ahmed, MD
Medical Director, Abbott
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2015
First Posted
November 25, 2015
Study Start
November 1, 2015
Primary Completion
March 1, 2017
Study Completion
May 1, 2017
Last Updated
May 11, 2017
Record last verified: 2017-05