Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT05646433
Status:
UNKNOWN
Last Update Posted:
2023-07-06
First Post:
2022-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a New Score for UGI Bleeding in the ED: the Study of the TU-GIB Score
Sponsor:
Hôpital Universitaire Sahloul
Organization:
Study Overview
Official Title:
Validation of a New Tunisian Risk Score for Upper Gastrointestinal Bleeding in the Emergency Room: Study of the TU-GIB Score
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TU-GIBscore
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: