External Validation of the Glasgow-Blatchford Bleeding Score in a Tunisian Population
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHôpital Universitaire Sahloul
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥18 years) presenting with non-traumatic upper gastrointestinal bleeding
Disqualifiers
patients under 18 years of age.
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 1 trial groupGroup A: Patients consulting with Upper gastrointestinal bleeding
Trial outcomes
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 daysSponsors and contacts
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Source ClinicalTrials.gov