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Upper Gastrointestinal Bleeding (UGIB)NCT07089277

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

An observational study of Upper Gastrointestinal Bleeding (UGIB) and Glasgow-Blatchford Score, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
250 participants
Where
1 siteTunisia
Study dates
1 Jan 2024to 30 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Riadh Boukef, Professor contact

+21698676745

boukef.riadh@famso.u-sousse.tn

Tunisia1 site, 1 recruiting
  • Sahloul University Hospital

    Sousse, 4021

    Rahma Jaballah, 55600033, jaballahrahma27@gmail.com

    Recruiting

Other trials in Tunisia

About this study

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.

Read more

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.

Medical subject headings
Gastrointestinal Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07089277
Study groupRoleWhat they receive
Patients consulting with Upper gastrointestinal bleedingconsulting ED with UGIB

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2025
  2. Study start1 Jan 2024
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07089277
Sponsor's protocol ID
UGIB
Status last verified
May 2025
First submitted
24 Apr 2025
Last updated
28 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Upper Gastrointestinal Bleeding (UGIB) and Glasgow-Blatchford Score, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Riadh Boukef, Professor (+21698676745, boukef.riadh@famso.u-sousse.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adverse outcomes such as rebleeding, the need for hemostatic intervention, complications and mortality at 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

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