- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07458178
A New Scoring System to Predict High-Risk Groups in Upper Gastrointestinal Bleeding (UGIS)
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
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Izmir, Turkey (Türkiye)
- Izmir Katip Çelebi University Faculty of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Demographic characteristics, presenting complaints, comorbid conditions, regularly used medications, mental status, vital signs, laboratory values, admission locations, blood transfusion requirements, endoscopic hemostasis procedures, radiological interventions, surgical procedures, length of stay (LOS), readmissions, and in-hospital mortality data were obtained from the electronic patient record system.
All data were recorded by a single physician using a pre-prepared data collection form.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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upper gastrointestinal bleeding
clinical manifestations of upper gastrointestinal bleeding (UGIB) and subsequently hospitalized during
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High-Risk upper gastrointestinal bleeding group
Patients were classified as high risk if they met at least one of the following criteria during hospitalization: Requirement for blood transfusion Endoscopic hemostatic intervention Radiological intervention Surgical intervention Intensive Care Unit (ICU) admission Re-bleeding In-hospital mortality This composite definition was used to reflect clinically significant deterioration or the need for advanced care. |
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Low risk upper gastrointestinal bleeding group
Patients who did not meet any of the above high-risk criteria during hospitalization were classified as low risk.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The primary outcome is the ability of the HOLD-B score to identify patients with high-risk upper gastrointestinal bleeding.
Time Frame: 1 year
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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). |
1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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compare the effectiveness of the newly developed risk score
Time Frame: 1 year
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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. |
1 year
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IZMIR-KCU-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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