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Completed

NCT Number: NCT07458178

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Izmir Katip Çelebi University Faculty of Medicine

Izmir, Turkey (Türkiye)

Who can participate

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

Treatment and study plan

Primary outcomes

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

    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).

Secondary outcomes

  1. compare the effectiveness of the newly developed risk score

    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.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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