|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02465619 |
|
Date of registration:
|
04/06/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
To Study and Compare the Clinical Course and Development of Organ Failure in Severe Acute Hepatitis Without Ascites, Non-cirrhotic and Cirrhotic Patients With Ascites [Acute on Chronic Liver Failure] and Acute Deterioration of Previously Decompensated Cirrhosis.
|
|
Scientific title:
|
To Study and Compare the Clinical Course and Development of Organ Failure in Severe Acute Hepatitis Without Ascites, Non-cirrhotic and Cirrhotic Patients With Ascites [Acute on Chronic Liver Failure] and Acute Deterioration of Previously Decompensated Cirrhosis. |
|
Date of first enrolment:
|
June 1, 2015 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
https://clinicaltrials.gov/show/NCT02465619 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
India
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- All consecutive patients presenting to hospital with bilirubin =5 and INR=1.5
- Cirrhosis with or without Decompensation presenting with acute deterioration in less
than 3 month
Exclusion Criteria:
- Cirrhosis with chronic decompensation.
- Patient on anticoagulant
- Hepatocellular carcinoma
- Septic shock
- Post-liver transplant or resection
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cirrhosis
|
|
Primary Outcome(s)
|
|
Survival
[Time Frame: 28 days]
|
|
Secondary Outcome(s)
|
|
Number of patients develop SIRS (Systemic Inflammatory Response Syndrome).
[Time Frame: 3 months]
|
|
Number of patients develop liver failure.
[Time Frame: 3 months]
|
|
total number of patients underwent Transplantation
[Time Frame: 3 months]
|
|
Mortality
[Time Frame: 3 months]
|
|
Number of patients develop sepsis.
[Time Frame: 3 months]
|
|
Survival
[Time Frame: 3 months]
|
|
Secondary ID(s)
|
|
ILBS-Cirrhosis-002
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|