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.
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
- Conditions the study is for
- Upper Gastrointestinal Bleeding (UGIB), Glasgow-Blatchford Score
- 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.
Tunisia1 site, 1 recruiting
- Recruiting
Sahloul University Hospital
Sousse, 4021
Rahma Jaballah, 55600033, jaballahrahma27@gmail.com
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 group | Role | What they receive |
|---|---|---|
| Patients consulting with Upper gastrointestinal bleeding | consulting ED with UGIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted28 Jul 2025
- Study start1 Jan 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal Bleeding (UGIB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Sahloul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riadh Boukef, Hôpital Universitaire Sahloul
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of the Glasgow-Blatchford Bleeding Score in a Tunisian Population
- ClinicalTrials.gov ID
- NCT07089277
- Acronym / sponsor ID
- UGIB
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hôpital Universitaire SahloulUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients consulting with Upper gastrointestinal bleeding | – | –consulting ED with UGIB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Adult patients (≥18 years) presenting with non-traumatic upper gastrointestinal bleeding
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
adverse outcomes such as rebleeding, the need for hemostatic intervention, complications and mortality at 30 days
Time frame: 30 days
adverse outcomes such as rebleeding, the need for hemostatic intervention, complications and mortality at 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.