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

NCT ID: NCT07089277

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-30

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.

Detailed Description

Introduction:

Acute gastrointestinal bleeding is a common reason for emergency department visits and is associated with significant morbidity and mortality. The emergency physician plays a crucial role in rapid diagnosis, risk stratification, and appropriate management [1]. Although the incidence of gastro-duodenal ulcers has decreased in recent years, they remain the most frequent cause of upper gastrointestinal bleeding [2].

Diagnostic and therapeutic approaches have significantly improved, particularly with the wider availability of endoscopy. However, early assessment of bleeding severity and prognostic risk remains essential in patient management. Several prognostic scoring systems have been proposed, but few have been validated or widely adopted in clinical practice [2].

In Tunisia, as in many developing countries, a major challenge is the routine hospitalization of all patients for monitoring, although only a subset will develop complications. The use of prognostic scores such as the Glasgow-Blatchford Score could allow for better identification of at-risk patients and more targeted therapeutic strategies [3-4].

The Glasgow-Blatchford Score (GBS) is a widely used predictive tool for assessing the risk of severe complications in patients with upper gastrointestinal bleeding. However, its performance and validity have been minimally studied in the Tunisian population. This study aims to validate the Glasgow-Blatchford Score in a Tunisian cohort to confirm its relevance and utility in a local clinical context [5-7].

Objective:

The objective of this study is to perform an external validation of the Glasgow-Blatchford Score in a Tunisian population. We aim to assess its ability to predict adverse outcomes such as rebleeding, the need for hemostatic intervention, complications, and 30-day mortality.

Materials and Methods:

This will be a multicenter, descriptive, and analytical study conducted in the emergency departments of several hospitals in Tunisia. 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.

Methodology:

Patient clinical data will be collected using a structured data collection form, which will include the Glasgow-Blatchford Score criteria along with epidemiological and clinical characteristics. Patients will be followed up via telephone on Day 30 to record any adverse events (rebleeding, need for hemostatic therapy, complications, and death).

Statistical Analysis:

Data will be entered and analyzed using SPSS version 26.0. The performance of the Glasgow-Blatchford Score will be assessed in terms of sensitivity, specificity, positive and negative predictive values, and its ability to predict 30-day mortality and complications.

Conditions

Upper Gastrointestinal Bleeding (UGIB); Glasgow-Blatchford Score

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients consulting with Upper gastrointestinal bleeding

consulting ED with UGIB

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Universitaire Sahloul

OTHER

Sponsor Role: lead

Responsible Party

Riadh Boukef

Riadh Boukef

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sahloul University Hospital

Sousse, , Tunisia

Site Status: RECRUITING

Countries

Tunisia

Central Contacts

Riadh Boukef, Professor

Role: CONTACT

boukef.riadh@famso.u-sousse.tn

+21698676745

Facility Contacts

Rahma Jaballah

Role: primary

jaballahrahma27@gmail.com

55600033

Other Identifiers

UGIB

Identifier Type: -

Identifier Source: org_study_id