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RecruitingNCT07089277Updated Jul 28, 2025

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

An observational study in Upper Gastrointestinal Bleeding (UGIB) and Glasgow-Blatchford Score, sponsored by Hôpital Universitaire Sahloul. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-28.

Sponsored by Hôpital Universitaire Sahloul · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Upper Gastrointestinal Bleeding (UGIB)
  • Glasgow-Blatchford Score
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

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.

04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients consulting with Upper gastrointestinal bleeding

    consulting ED with UGIB

05

What researchers measure

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

    Time frame: 30 days

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07089277
Lead sponsor
Hôpital Universitaire Sahloul
Responsible party
Riadh Boukef (Riadh Boukef, Hôpital Universitaire Sahloul) — Principal investigator
First posted
Jul 28, 2025
Start date
Jan 1, 2024
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Jul 28, 2025

Study contacts

Riadh Boukef, Professor
Contact
boukef.riadh@famso.u-sousse.tn
+21698676745

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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