Izmir Katip Çelebi University Faculty of Medicine
Izmir, Turkey (Türkiye)
NCT Number: NCT07458178
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.
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Notify Me18 year and older
All sexes
Observational
Izmir, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age ≥18 years
Consecutive patients presenting to the emergency department between January 2024 and January 2026
Clinical presentation suggestive of upper gastrointestinal bleeding, including hematemesis, melena, or hematochezia suspected to originate from the upper gastrointestinal tract due to rapid intestinal transit
Patients who underwent upper gastrointestinal endoscopy during the index hospitalization
Presence of endoscopic findings confirming upper gastrointestinal pathology
Availability of complete clinical, laboratory, and outcome data in the hospital information management system
Patients evaluated and managed in the Emergency Department of İzmir Atatürk Training and Research Hospital
Exclusion criteria
Age <18 years
Patients presenting with cardiac arrest at admission
Intubated patients at the time of emergency department presentation
Presence of concomitant active infectious diseases
Patients diagnosed with esophageal variceal bleeding
Use of medications known to increase serum lactate levels, including:
metformin
β2-agonists
methotrexate
zidovudine
linezolid
Patients with missing or incomplete clinical or laboratory data
Patients whose hospital outcomes could not be determined during follow-up
Time frame: 1 year
The HOLD-B score (Hemoglobin, Lactate, Diastolic Blood Pressure, Blood Urea Nitrogen) is a risk stratification score developed in this study. The score ranges from 0 to 6, where higher scores indicate a higher probability of high-risk clinical outcomes.
Based on ROC analysis, the optimal cut-off value is 3.5.
High-risk upper gastrointestinal bleeding was defined as the occurrence of at least one of the following events during hospitalization:
blood transfusion
endoscopic hemostatic intervention
intensive care unit admission
rebleeding
in-hospital mortality
Predictive performance will be evaluated using receiver operating characteristic (ROC) curve analysis and area under the curve (AUC).
Time frame: 1 year
The predictive performance of the HOLD-B score will be compared with commonly used upper gastrointestinal bleeding risk scores, including:
Glasgow-Blatchford Score (GBS) Rockall Score Pre-endoscopic Rockall Score AIMS65 Score ABC Score (Age, blood tests, comorbidities) H3B2 Score (Hemodynamic Instability, Hemoglobin, Hematemesis, Blood Urea Nitrogen (BUN), Melena) ABL Score (systolic blood pressure, hemoglobin, BUN/Creatinine, INR/Albumin) Lactate/Hemoglobin Discriminative performance will be evaluated using ROC curve analysis, and AUC values will be compared using the DeLong test.
Izmir Katip Celebi University
Other
A New Scoring System to Predict High-Risk Groups in Upper Gastrointestinal Bleeding and Comparison of the Found Score With Scoring Systems in the Literature
Acronym: UGIS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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