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

NCT07458178 | Completed DMC

• 1 other identifier: IZMIR-KCU-03
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Upper Gastrointestinal Bleeding (UGIB); High Risk Bleeding

Keywords

Upper Gastrointestinal Bleeding; risk scores; high risk bleeding

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the ability of the HOLD-B score to identify patients with high-risk upper gastrointestinal bleeding.

  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

Secondary Outcomes (1)

• compare the effectiveness of the newly developed risk score

  1 year

Study Arms (3)

upper gastrointestinal bleeding

clinical manifestations of upper gastrointestinal bleeding (UGIB) and subsequently hospitalized during

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Çelebi University Faculty of Medicine

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

• Guner NG, Catal F, Yurumez Y, Guneysu F, Bostanci F. Comparison of the new risk score (ABL) with the Glasgow Blatchford Score, AIMS65, and pre-endoscopic Rockall Score in patients with upper gastrointestinal bleeding admitted to the emergency department. BMC Emerg Med. 2025 Jul 18;25(1):131. doi: 10.1186/s12873-025-01291-z.

  PMID: 40681998 RESULT

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD Assoc. Prof.

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 9, 2026
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)