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At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,739 enrolled
Drug / intervention
No special intervention was suitable for this observational studyother
Likely dose
Not stated in record
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Search/NCT03992898
NCT03992898N/ACompleted

Establishment and Validation of Prognostic Nomograms for HBV-related Acute-on-Chronic Liver Failure in South of China

Sun Yat-sen University·observational·Posted Jun 20, 2019·Updated Jan 6, 2020

In Brief

An observational study evaluating No special intervention was suitable for this observational study for Liver Failure. Completed, enrolled 2,739 participants across 1 site.

Detailed Summary

Acute-on-chronic liver failure (ACLF) is an acute deterioration of chronic liver diseases, which progresses rapidly, with a mortality rate of more than 50%.MELD score is used to evaluate the patients' condition. However, MELD score only concerned about the variables of total bilirubin, international normalize ratio (INR) and creatinine which is not enough to access ACLF patients' condition accurately. Scholars of US and China suggested to divided ACLF patients into 3 subgroups base on the different "chronic liver disease" . Type A ACLF patients have chronic liver disease without cirrhosis. Type B ACLF patients with compensated cirrhosis, while type C ACLF patients with decompensated cirrhosis. Currently, no studies have assessed the prognosis of different types of ACLF patients, especially for HBV-related ACLF patients. Investigators conducted a retrospective study which enrolls HBV-related ACLF patients between January 2010 and March 2018 in the Third Affiliated Hospital of Sun Yat-sen University. Clinical data, survival time and information regarding liver transplantation after enrolment were collected. A nomogram was formulated based on the results of multivariable Cox regression analysis. The performance of the nomogram was evaluated by the concordance index (C-index) and assessed by comparing nomogram-predicted vs observed Kaplan-Meier estimates of survival probability, and bootstraps with 1000 resamples were applied to these activities. Comparisons between the nomogram, MELD Score,MELD-Na Score and CTP Score in the entire population were performed and were tested by the C-index. A larger C-index indicated more accurate prognostic stratification.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Failure
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 20, 2019
Enrollment StartJan 1, 2019
Primary CompletionOct 1, 2019
Study CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.0 years ago

Interventions

No special intervention was suitable for this observational studyother

Investegators divided patients into 3 corhort according to the liver condition at enrollment (i.e. chronic liver disease, compemsated cirrhosis, decompensated cirrhosis). All patients received standard medical treatment, including nutritional supplementation; administration of human serum albumin, fresh frozen plasma, antivirus treatment and appropriate treatment for complications. No special intervention was suitable for this observational study.