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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07458178
Acronym
UGIS
Enrollment
312
Registered
2026-03-09
Start date
2024-01-01
Completion date
2026-01-01
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Risk Bleeding, Upper Gastrointestinal Bleeding (UGIB)

Keywords

Upper Gastrointestinal Bleeding, risk scores, high risk bleeding

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.

Interventions

None listed

Sponsors

Izmir Katip Celebi University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome is the ability of the HOLD-B score to identify patients with high-risk upper gastrointestinal bleeding.1 yearThe 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).

Secondary

MeasureTime frameDescription
compare the effectiveness of the newly developed risk score1 yearThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026