Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181448
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-26
First Post:
2023-12-13
Brief Title:
Real-World Validation of a Prognostic Prediction Model for Patients With Acute Exacerbations of Chronic Liver Disease
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
Real-World Validation of a Prognostic Prediction Model for Patients With Acute Exacerbations of Chronic Liver Disease A Multi-Site Prospective Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our study is a multi-site prospective observational study including patients with acute exacerbations of CLD Approximately 1500 patients from 24 hospitals in diverse regions in China will be enrolled and followed for 3 months Data about demographic data laboratory tests and clinical manifestations collected through a mobile application will inform real-time prognostic scores The aim of this study is to validate the models real-world applicability in non-specialist hospital settings
Detailed Description:
The study is a multi-site prospective observational study conducted in 24 hospitals representing different regions across China The choice of 24 hospitals was based on their representation of diverse geographical regions across China These hospitals were selected to ensure a comprehensive validation of the screening models efficacy in varied healthcare settings Data will be collected through a mobile application providing real-time prognostic scores for patients The study is divided into three parts patient recruitment in-hospital follow-up and post-discharge follow-up Follow-up will last for 3 months Endpoints will be considered for all-cause death survival and liver transplantation The study is planned to enroll 1500 patients from January 2024 to January 2026
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None