Clinical Trial

A New Scoring System to Predict High-Risk Groups in Upper Gastrointestinal Bleeding

Study acronym: UGIS
Completed
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Summary
Upper gastrointestinal bleeding (UGIB) remains a common and potentially life-threatening emergency condition requiring early risk stratification to guide clinical management. Although several validated scoring systems such as Rockall, Glasgow-Blatchford Score (GBS), AIMS65, H3B2, ABC, ABL, and Pre-endoscopic Rockall (Pre-RS) are widely used, their discriminative performance for identifying patients at high clinical risk varies across populations. This retrospective, single-center observational study included 312 adult patients admitted to the emergency department between January 2024 and January 2026 with clinical manifestations of UGIB. Patients were categorized into high-risk and low-risk groups based on clinically significant outcomes, including transfusion requirement, endoscopic/radiological/surgical intervention, intensive care unit admission, rebleeding, or in-hospital mortality. The primary objective was to develop a novel risk score (HOLD\_B), derived from independent predictors identified through multivariable logistic regression analysis. Receiver Operating Characteristic (ROC) curve analysis was used to determine optimal cut-off values for continuous predictors and to evaluate discriminative performance. The newly developed score was compared with established scoring systems using area under the curve (AUC) analysis and DeLong's test for pairwise comparisons. The study aims to provide a simplified and clinically applicable risk stratification tool for early identification of high-risk UGIB patients in the emergency department setting.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-03.
Trial Details
NCT Number NCT07458178
Lead Sponsor Izmir Katip Celebi University
Conditions Upper Gastrointestinal Bleeding (UGIB), High Risk Bleeding
Enrollment 312 participants
Start Date 2024-01-01
Primary Completion 2026-01-01 (estimated)
Study Completion 2026-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-13