Gastro Intestinal BleedTU-GIBscoreNCT05646433
Validation of a New Score for UGI Bleeding in the ED: the Study of the TU-GIB Score
An observational study of Gastro Intestinal Bleed, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastro Intestinal Bleed
- How many people
- 500 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Jun 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: multicentric, descriptive and analytical study in different emergency departments
Who may be able to join
- patients consulting the emergency room for upper GI hemorrhage of non-traumatic origin.
- Age >18 years
Who cannot join
- patient under the age of 18
- Lower gastrointestinal hemorrhag
- diagnosis of external hemorrhoids / perianal lesions
- Not consenting
- The lost sight
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Sahloul University Hospital
Sousse, 5000
riadh boukef, professor, 98676745 ext. 216, riadboukef@gmail.com
About this study
Official title: 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.
Read the 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
- Conditions
- Gastro Intestinal Bleed
- Keywords
- Upper Gastro intestinal bleeding; TU-GIB score; ED
- Medical subject headings
- Gastrointestinal Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was all-cause in-hospital mortality rate
The primary outcome was all-cause in-hospital mortality rate
Measured: 30 days after inclusion
Secondary outcomes (1)
re-bleeding, re-hospitalization, discharge
Hemorrhagic recurrence is defined by recurrence of hematemesis, melena or rectal bleeding after discharge from hospital within 30 days
Measured: 30 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start2 Jun 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Intestinal BleedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Sahloul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riadh Boukef, Hôpital Universitaire Sahloul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646433
- Sponsor's protocol ID
- TU-GIBscore
- Acronym
- TU-GIBscore
- Status last verified
- Jul 2023
- First submitted
- 3 Dec 2022
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Tunisian Risk Score for Upper Gastrointestinal Bleeding in the Emergency Room: Study of the TU-GIB Score
- ClinicalTrials.gov ID
- NCT05646433
- Acronym / sponsor ID
- TU-GIBscore / TU-GIBscore
- Conditions
- Gastro Intestinal Bleed
- Keywords
- Upper Gastro intestinal bleeding; TU-GIB score; ED
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hôpital Universitaire SahloulUniversity, hospital or other
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- multicentric, descriptive and analytical study in different emergency departments
Key inclusion criteria (2 listed)
- patients consulting the emergency room for upper GI hemorrhage of non-traumatic origin.
- Age >18 years
Key exclusion criteria (5 listed)
- patient under the age of 18
- Lower gastrointestinal hemorrhag
- diagnosis of external hemorrhoids / perianal lesions
- Not consenting
- The lost sight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome was all-cause in-hospital mortality rate
Time frame: 30 days after inclusion
The primary outcome was all-cause in-hospital mortality rate
1 secondary outcome
re-bleeding, re-hospitalization, discharge
Time frame: 30 days after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro Intestinal Bleed, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Riadh Boukef, professor (0021698676745, riadboukef@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was all-cause in-hospital mortality rate (time frame: 30 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.