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The purpose of this study is to identify factors that predict the development of decompensation, acute-on-chronic liver failure (ACLF) and death in patients with liver cirrhosis. Clinical data will be retrieved from existing hospital records. This information may help doctors to identify patients with cirrhosis who are at risk of deterioration earlier (before they develop complications) and to develop effective treatment strategies to prevent or delay these complications.
This study is designed as a prospective, non-interventional, observational study. This means that if you agree to participate in the study, you will not be required to undergo any additional hospital visits, tests, procedures or interventions other than the usual standard-of-care management that your doctor will provide. If you consent to participate in this study, you will be providing the study investigators permission to review and analyse your clinical data from the hospital clinical records. Your data will be collected throughout the course of your disease until liver transplantation or death.
The primary aim of this study is to prospectively identify factors that predict decompensation, ACLF and death in patients with cirrhosis.
Specific goals of the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with liver cirrhosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | Patients with liver cirrhosis will be observed to monitor for death |
|
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | Death from any cause will be recorded during the study period | Up to 10 years from date of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Decompensation of liver cirrhosis | Occurence of first episode of hepatic decompensation, defined as the development of any of the following clinical events: variceal bleeding, hepatic encephalopathy, ascites, hepatocellular carcinoma, portal vein thrombosis, sepsis and acute-on-chronic liver failure (ACLF). Diagnosis will be based on standard clinical, laboratory or imaging criteria. These data will be retrieved from hospital clinical records. |
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Inclusion Criteria:
Exclusion Criteria:
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This multicenter study aims to recruit 2,200 cirrhotic patients over a 5 year period from 3 institutions in SingHealth - Changi General Hospital (CGH), Sengkang General Hospital (SKH) and Singapore General Hospital (SGH).
Patients will be recruited both from the inpatient and outpatient setting. All consecutive patients admitted/referred to the study center with a clinical diagnosis of liver cirrhosis (based on standard clinical, radiological, elastography and/or histological criteria) will be offered inclusion into the SoLiDaRity-DAM study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason Pik Eu Chang, MBBS, MRCP | Contact | +65 6321 4684 | jason.chang@singhealth.com.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Recruiting | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32673741 | Background | Trebicka J, Fernandez J, Papp M, Caraceni P, Laleman W, Gambino C, Giovo I, Uschner FE, Jimenez C, Mookerjee R, Gustot T, Albillos A, Banares R, Janicko M, Steib C, Reiberger T, Acevedo J, Gatti P, Bernal W, Zeuzem S, Zipprich A, Piano S, Berg T, Bruns T, Bendtsen F, Coenraad M, Merli M, Stauber R, Zoller H, Ramos JP, Sole C, Soriano G, de Gottardi A, Gronbaek H, Saliba F, Trautwein C, Ozdogan OC, Francque S, Ryder S, Nahon P, Romero-Gomez M, Van Vlierberghe H, Francoz C, Manns M, Garcia E, Tufoni M, Amoros A, Pavesi M, Sanchez C, Curto A, Pitarch C, Putignano A, Moreno E, Shawcross D, Aguilar F, Claria J, Ponzo P, Jansen C, Vitalis Z, Zaccherini G, Balogh B, Vargas V, Montagnese S, Alessandria C, Bernardi M, Gines P, Jalan R, Moreau R, Angeli P, Arroyo V; PREDICT STUDY group of the EASL-CLIF Consortium. The PREDICT study uncovers three clinical courses of acutely decompensated cirrhosis that have distinct pathophysiology. J Hepatol. 2020 Oct;73(4):842-854. doi: 10.1016/j.jhep.2020.06.013. Epub 2020 Jul 13. |
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Anonymized data on baseline clinical characteristics and liver related outcomes
Aug 2022 to Aug 2027
Potential research collaborators (e.g. to publish meta-analysis or external validation studies)
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2025 | Sep 17, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 7, 2025 | Sep 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D065290 | Acute-On-Chronic Liver Failure |
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| 10 years |
| Sengkang General Hospital | Recruiting | Singapore | Singapore |
|
| Singapore General Hospital | Recruiting | Singapore | Singapore |
|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |