External Validation of the Glasgow-Blatchford Bleeding Score in a Tunisian Population

NCT07089277 | Recruiting DMC

• 1 other identifier: UGIB
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to externally validate the Glasgow-Blatchford Score (GBS) in a Tunisian population presenting with non-traumatic upper gastrointestinal bleeding. Despite advances in endoscopic management, early risk stratification remains essential to guide clinical decision-making. In Tunisia, the routine hospitalization of all patients for observation presents a challenge, highlighting the need for reliable prognostic tools. The study is designed as a multicenter, descriptive, and analytical investigation across several emergency departments. Adult patients (≥16 years) will be included, with follow-up conducted at 30 days to assess for adverse outcomes including rebleeding, the need for hemostasis, complications, and mortality. Clinical and epidemiological data will be collected using a standardized form. Statistical analysis will evaluate the predictive performance of the GBS, focusing on sensitivity, specificity, and predictive values for 30-day outcomes. The results are expected to determine whether GBS is a valid and useful tool for risk assessment in the Tunisian context, potentially aiding in more efficient and targeted patient management.

Conditions

Upper Gastrointestinal Bleeding (UGIB); Glasgow-Blatchford Score

Outcome Measures

Primary Outcomes (1)

• adverse outcomes such as rebleeding, the need for hemostatic intervention, complications and mortality at 30 days

  adverse outcomes such as rebleeding, the need for hemostatic intervention, complications and mortality at 30 days

  30 days

Study Arms (1)

Patients consulting with Upper gastrointestinal bleeding

consulting ED with UGIB

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

Patients included in the study will have presented to the emergency department with non-traumatic upper gastrointestinal bleeding. Inclusion Criteria: Adult patients (≥16 years) presenting with non-traumatic upper gastrointestinal bleeding. Exclusion Criteria: Patients under 16 years of age. Diagnosis of external hemorrhoids with mucosal lesions. Patients who do not consent, are lost to follow-up, or have incomplete data. All patients must provide informed consent to participate in the study, and confidentiality will be maintained in accordance with ethical principles in clinical research.

You may qualify if:

• Adult patients (≥18 years) presenting with non-traumatic upper gastrointestinal bleeding

You may not qualify if:

• patients under 18 years of age.
• Diagnosis of external hemorrhoids with mucosal lesions.
• Patients who do not consent, are lost to follow-up, or have incomplete data.

Sponsors & Collaborators

• Hôpital Universitaire Sahloul: lead

Study Sites (1)

Sahloul University Hospital

Sousse, 4021, Tunisia

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Riadh Boukef, Professor

CONTACT

+21698676745; boukef.riadh@famso.u-sousse.tn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Riadh Boukef

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: July 28, 2025
• Study Start: January 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)