Validation of a New Score for UGI Bleeding in the ED: the Study of the TU-GIB Score

Recruiting

• Conditions: Gastro Intestinal Bleed

• Registration Number: NCT05646433
• Lead Sponsor: Hôpital Universitaire Sahloul

Brief Summary

We have developed a new reliable, easy and reproducible clinical and biological score to select patients presenting to the emergency department with upper GI bleeding and at high risk of developing complications in order to plan an adequate management.

This score was compared to the Glasgow-Blatchford score and showed better results in predicting rebleeding, the need for hemostasis therapy and any complications at day 30 including mortality.

In a second step and as an objective of this study, it is necessary to perform an external validation of this score in different emergency departments.

Detailed Description

We have developed a new reliable, easy and reproducible clinical and biological score to select patients presenting to the emergency department with upper GI bleeding and at high risk of developing complications in order to plan an adequate management.

This score was compared to the Glasgow-Blatchford score and showed better results in predicting rebleeding, the need for hemostasis therapy and any complications at day 30 including mortality.

In a second step and as an objective of this study, it is necessary to perform an external validation of this score in different emergency departments.

We will conduct a multicenter, descriptive and analytical study in different emergency departments Inclusion criteria: patients consulting the emergency department for upper GI hemorrhage of non-traumatic origin.

Exclusion criteria: patients under 18 years of age, diagnosed with external hemorrhoids with parietal lesions. We exclude any patient who does not consent, is lost to follow-up or has incomplete information.

Anonymity and confidentiality of the data were respected. Data collection was carried out using a data processing form designed for the purpose of this work, including descriptive analysis of the epidemiological and clinical characteristics of the patients, as well as the para-clinical data.

Patients were followed up by telephone call at D30 to record the date and cause of any complications noted, such as rebleeding, hospitalization, or death.

The data will be entered and analyzed in SPSS 21.0

Study Timeline

• Study First Submitted: 2022-12-03
• Study First Submitted QC: 2022-12-03
• Study First Posted: 2022-12-12
• Study Start: 2023-06-02
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-06
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• patients consulting the emergency room for upper GI hemorrhage of non-traumatic origin.
• Age >18 years

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Exclusion Criteria

• patient under the age of 18
• Lower gastrointestinal hemorrhag
• diagnosis of external hemorrhoids / perianal lesions
• Not consenting
• The lost sight

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome was all-cause in-hospital mortality rate	30 days after inclusion	The primary outcome was all-cause in-hospital mortality rate

Secondary Outcome Measures

Name	Time	Method
re-bleeding, re-hospitalization, discharge	30 days after inclusion	Hemorrhagic recurrence is defined by recurrence of hematemesis, melena or rectal bleeding after discharge from hospital within 30 days

Trial Locations

Locations (1)

Sahloul University Hospital; 🇹🇳 Sousse, Tunisia