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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05646433
Acronym
TU-GIBscore
Enrollment
500
Registered
2022-12-12
Start date
2023-06-02
Completion date
2023-12-31
Last updated
2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro Intestinal Bleed

Keywords

Upper Gastro intestinal bleeding; TU-GIB score; ED

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

Interventions

None listed

Sponsors

Hôpital Universitaire Sahloul
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome was all-cause in-hospital mortality rate30 days after inclusionThe primary outcome was all-cause in-hospital mortality rate

Secondary

MeasureTime frameDescription
re-bleeding, re-hospitalization, discharge30 days after inclusionHemorrhagic recurrence is defined by recurrence of hematemesis, melena or rectal bleeding after discharge from hospital within 30 days

Countries

Tunisia

Contacts

Primary ContactRiadh Boukef, professor
riadboukef@gmail.com0021698676745

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026