NCT01863121

Brief Summary

The CTP score is one of the best proved severity score in predicting mortality in patients with cirrhosis. Portal hypertension and variceal bleed are significant causes of morbidity and mortality in patients with cirrhosis. The recently published CTPK score included variceal variceal bleed status to the CTP score which improved the accuracy of CTP score in predicting short term mortality. CTPK score needs prospective validation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2013

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

4.7 years

First QC Date

May 21, 2013

Last Update Submit

April 27, 2017

Conditions

Cirrhosis

Keywords

cirrhosisCTPKCTPMELDSeverity Score

Outcome Measures

Primary Outcomes (1)

  • 1-week Survival

    Severity assessment of cirrhosis will be done by CTP score, MELD score and in addition by CTPK score. Patients will be treated as per discretion of treating physician. Survival will be assessed at 1 week

    1 week

Secondary Outcomes (5)

  • 2-week Survival

    2 weeks

  • 1-month Survival

    1 month

  • 2-month Survival

    2 months

  • 3-month Survival

    3 months

  • 6-month Survival

    6 months

Study Arms (1)

Cirrhotic Patients

Patients of cirrhosis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient of cirrhosis Age between 18 - 75 years

You may qualify if:

  • Patient of cirrhosis
  • Age between 18 - 75 years
  • Admitted in Unit 1 Department of Gastroenterology \& Hepatology
  • Patients/ LAR who are willing to give written informed consent

You may not qualify if:

  • Patients with significant cardiopulmonary illness
  • Any malignancy including HCC (Hepatocellular Carcinoma)
  • Patients who refuse to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital

New Delhi, 110060, India

RECRUITING

Related Publications (1)

  • Kumar A, Sharma P, Sarin SK. Adding variceal status to Child-Turcotte-Pugh score improves its performance in predicting early mortality in cirrhosis: the Child-Turcotte-Pugh-Kumar score. Eur J Gastroenterol Hepatol. 2012 Nov;24(11):1348-9. doi: 10.1097/MEG.0b013e3283579475. No abstract available.

    PMID: 23022921BACKGROUND

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ashish kumar, M..D

    Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital

    PRINCIPAL INVESTIGATOR

  • Anil Arora, M.D

    Department of Gatroenterology & Hepatology, Sir Gnaga Ram Hospital

    PRINCIPAL INVESTIGATOR

  • Praveen Sharma, M.D

    Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital

    PRINCIPAL INVESTIGATOR

  • Pankaj tyagi, M.D

    Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashish Kumar, M.D

CONTACT

091-9312792573ashishk10@yahoo.com

Praveen Sharma, M.D

CONTACT

091-9540951004drpraveen_sharma@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor & Consultant

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 27, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

IN(1)