Clinical trial NCT05646433: Validation of a New Score for UGI Bleeding in the ED: the Study of the TU-GIB Score
Official title: Validation of a New Tunisian Risk Score for Upper Gastrointestinal Bleeding in the Emergency Room: Study of the TU-GIB Score
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastro Intestinal Bleed
Keywords: Upper Gastro intestinal bleeding; TU-GIB score; ED
Lead sponsor: Hôpital Universitaire Sahloul
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: multicentric, descriptive and analytical study in different emergency departments

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

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome was all-cause in-hospital mortality rate
timeFrame: 30 days after inclusion
Secondary outcomes:
measure: re-bleeding, re-hospitalization, discharge
timeFrame: 30 days after inclusion
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: Sahloul University Hospital
Study officials:
References: