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

Validation of a New Tunisian Risk Score for Upper Gastrointestinal Bleeding in the Emergency Room: Study of the TU-GIB Score

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.

Study Overview

• Status: Recruiting
• Conditions: Gastro Intestinal Bleed

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Riadh Boukef, professor; Phone Number: 0021698676745; Email: riadboukef@gmail.com

Study Locations

• Tunisia
  • Sousse, Tunisia, 5000
    • Recruiting
    • Sahloul University Hospital
    • Contact: riadh boukef, professor; Phone Number: 216 98676745; Email: riadboukef@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

multicentric, descriptive and analytical study in different emergency departments

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome was all-cause in-hospital mortality rate	The primary outcome was all-cause in-hospital mortality rate	30 days after inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hôpital Universitaire Sahloul

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: December 3, 2022
• First Submitted That Met QC Criteria: December 3, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Upper Gastro intestinal bleeding; TU-GIB score; ED
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: TU-GIBscore

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No