Gastro Intestinal BleedingNCT05688501
Clinical-biological Score for Upper Gastrointestinal Bleeding
An observational study of Gastro Intestinal Bleeding, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
Trial summary
Gastrointestinal bleeding is a frequent reason for consultation in the Emergency Department. It is a real emergency associated with fairly significant morbidity and mortality. The incidence of upper gastrointestinal bleeding (HDH) has been reported to be 67-103 per 100,000 adults per year in the UK with mortality… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro Intestinal Bleeding
- What is being tested?
- descriptiv group
- How many people
- 150 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Sep 2019to 1 Sep 2022
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Upper gastrointestinal bleeding (HDH) was defined as a presentation with hematemesis, blackish vomiting and/or melena. Lower gastrointestinal hemorrhage (LBH) was defined as a presentation with red blood or blood clots or blood mixed with stool on clinical examination.
Who may be able to join
- Patients over the age of 18 consulting the emergency department of Sahloul Hospital in Sousse for exteriorized upper and/or lower digestive haemorrhage, of non-traumatic cause;
Who cannot join
- patient under the age of 18
- diagnosis of external hemorrhoids / perianal lesions
- Not consenting
- The lost sight
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
HU Sahloul, sousse, Tunisia
Sousse, Itinéraire Ceinture Cité Sahloul, 4054
About this study
Official title: Development of a New Reliable, Easy and Reproducible Clinical-biological Scale Allowing to Select Patients Consulting in the Emergency Department for Upper Gastrointestinal Bleeding
Gastrointestinal bleeding is a frequent reason for consultation in the Emergency Department. It is a real emergency associated with fairly significant morbidity and mortality.
The incidence of upper gastrointestinal bleeding (HDH) has been reported to be 67-103 per 100,000 adults per year in the UK with mortality rates of 2%-8%.
While Lower Gastrointestinal Bleeding (LBHB) has a lower incidence estimated at 33 per 100,000 adults per year. Additionally, compared to HDB, HDB appears to have less need for hemostatic intervention and lower mortality.
Read the detailed description
Gastrointestinal bleeding is a frequent reason for consultation in the Emergency Department. It is a real emergency associated with fairly significant morbidity and mortality.
The incidence of upper gastrointestinal bleeding (HDH) has been reported to be 67-103 per 100,000 adults per year in the UK with mortality rates of 2%-8%.
While Lower Gastrointestinal Bleeding (LBHB) has a lower incidence estimated at 33 per 100,000 adults per year. Additionally, compared to HDB, HDB appears to have less need for hemostatic intervention and lower mortality.
Despite a decrease in incidence, the first cause of upper gastrointestinal bleeding remains peptic ulcer. That of lower digestive hemorrhage is diverticular hemorrhage, the incidence of which increases with the aging of the population.
Over time, the overall management of these haemorrhages has improved, in particular with better availability of endoscopic exploration from the emergency room consultation. However, the average time for digestive endoscopy was reported at 16 hours in a North African study published in 2012. Measures should be put in place to further improve access to endoscopy services for these patients, being given that a fifth of them received this care with delays exceeding 48 to 72 hours.
The indication of endoscopic exploration and its delay comes up against various practical difficulties. Hence the assessment of severity and the progressive risk of aggravation is essential for the emergency physician. Several prognostic or predictive clinical scores for worsening have been proposed. These scores remain underused and rarely applied to support and guide the therapeutic strategy.
These published prognostic scores aim to determine the risk of mortality, recurrence of bleeding and to identify patients requiring hospital treatment (transfusion, endoscopic or surgical treatment). Their interest lies in their ability to identify high-risk patients, for whom aggressive management is required, as well as low-risk patients for whom management could be delayed.
Indeed, in Tunisia, as for the vast majority of developing countries, one of the problems posed by the management of HDH remains the hospitalization of a majority of patients for monitoring, while only 1928% of between them will develop complications. These scores could be of great help in supporting and guiding the therapeutic strategy.
Among the predictive scores, it was found that "The Glasgow-Blatchford score", which is specific only to HDH and which aims to determine which patients are "low risk" and therefore candidates for outpatient management. Another score, the Rockall score, stratifies the risk of re-bleeding and death but requires endoscopic data provided by an emergency examination. These data remain missing in most cases, at least during the first hours of patient care.
Regardless of the source of bleeding, early identification of patients at high risk of mortality could allow targeted management, including specialist care and early interventions that may improve outcomes. At the other end of the spectrum, patients identified as being at very low risk of complications may benefit from less intensive management, which would help target resources to the appropriate patients.
Recent international recommendations concerning the management of these patients recommend the use of these scores in the emergency department for risk stratification.
- Conditions
- Gastro Intestinal Bleeding
- Being tested
- descriptiv group
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
descriptiv groupOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
re-bleeding
Hemorrhagic recurrence is defined by recurrence of hematemesis, melena or rectal bleeding after discharge from hospital within 30 days
Measured: 30 days
re-hospitalization
re- hospitalisation for Hemorrhagic recurrence is defined by recurrence of hematemesis, melena or rectal bleeding after discharge from hospital within 30 days
Measured: 30 days
All cause mortality
The primary outcome was all-cause in-hospital mortality rate
Measured: 30 days
comparaison with the glasgow blatchford score
comparaison with the glasgow blatchford score
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Sep 2019
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Intestinal BleedingStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Sahloul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riadh Boukef, Hôpital Universitaire Sahloul
- Investigators
- Riadh Boukef, professor, Principal investigator, CHU Sahloul, Emergency department, sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688501
- Sponsor's protocol ID
- GIB-ED
- Status last verified
- Jan 2023
- First submitted
- 29 Nov 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: after publication of the article
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Reliable, Easy and Reproducible Clinical-biological Scale Allowing to Select Patients Consulting in the Emergency Department for Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT05688501
- Acronym / sponsor ID
- GIB-ED
- Conditions
- Gastro Intestinal Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hôpital Universitaire SahloulUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 18 Jan 2023 (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.
Gastrointestinal bleeding is a frequent reason for consultation in the Emergency Department. It is a real emergency associated with fairly significant morbidity and mortality.
The incidence of upper gastrointestinal bleeding (HDH) has been reported to be 67-103 per 100,000 adults per year in the UK with mortality rates of 2%-8%.
While Lower Gastrointestinal Bleeding (LBHB) has a lower incidence estimated at 33 per 100,000 adults per year. Additionally, compared to HDB, HDB appears to have less need for hemostatic intervention and lower mortality.
Detailed description
Gastrointestinal bleeding is a frequent reason for consultation in the Emergency Department. It is a real emergency associated with fairly significant morbidity and mortality.
The incidence of upper gastrointestinal bleeding (HDH) has been reported to be 67-103 per 100,000 adults per year in the UK with mortality rates of 2%-8%.
While Lower Gastrointestinal Bleeding (LBHB) has a lower incidence estimated at 33 per 100,000 adults per year. Additionally, compared to HDB, HDB appears to have less need for hemostatic intervention and lower mortality.
Despite a decrease in incidence, the first cause of upper gastrointestinal bleeding remains peptic ulcer. That of lower digestive hemorrhage is diverticular hemorrhage, the incidence of which increases with the aging of the population.
Over time, the overall management of these haemorrhages has improved, in particular with better availability of endoscopic exploration from the emergency room consultation. However, the average time for digestive endoscopy was reported at 16 hours in a North African study published in 2012. Measures should be put in place to further improve access to endoscopy services for these patients, being given that a fifth of them received this care with delays exceeding 48 to 72 hours.
The indication of endoscopic exploration and its delay comes up against various practical difficulties. Hence the assessment of severity and the progressive risk of aggravation is essential for the emergency physician. Several prognostic or predictive clinical scores for worsening have been proposed. These scores remain underused and rarely applied to support and guide the therapeutic strategy.
These published prognostic scores aim to determine the risk of mortality, recurrence of bleeding and to identify patients requiring hospital treatment (transfusion, endoscopic or surgical treatment). Their interest lies in their ability to identify high-risk patients, for whom aggressive management is required, as well as low-risk patients for whom management could be delayed.
Indeed, in Tunisia, as for the vast majority of developing countries, one of the problems posed by the management of HDH remains the hospitalization of a majority of patients for monitoring, while only 1928% of between them will develop complications. These scores could be of great help in supporting and guiding the therapeutic strategy.
Among the predictive scores, it was found that "The Glasgow-Blatchford score", which is specific only to HDH and which aims to determine which patients are "low risk" and therefore candidates for outpatient management. Another score, the Rockall score, stratifies the risk of re-bleeding and death but requires endoscopic data provided by an emergency examination. These data remain missing in most cases, at least during the first hours of patient care.
Regardless of the source of bleeding, early identification of patients at high risk of mortality could allow targeted management, including specialist care and early interventions that may improve outcomes. At the other end of the spectrum, patients identified as being at very low risk of complications may benefit from less intensive management, which would help target resources to the appropriate patients.
Recent international recommendations concerning the management of these patients recommend the use of these scores in the emergency department for risk stratification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Upper gastrointestinal bleeding (HDH) was defined as a presentation with hematemesis, blackish vomiting and/or melena. Lower gastrointestinal hemorrhage (LBH) was defined as a presentation with red blood or blood clots or blood mixed with stool on clinical examination.
Key inclusion criteria (1 listed)
- Patients over the age of 18 consulting the emergency department of Sahloul Hospital in Sousse for exteriorized upper and/or lower digestive haemorrhage, of non-traumatic cause;
Key exclusion criteria (4 listed)
- patient under the age of 18
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| descriptiv groupno intervention | Other | – |
Primary outcome
re-bleeding
Time frame: 30 days
Hemorrhagic recurrence is defined by recurrence of hematemesis, melena or rectal bleeding after discharge from hospital within 30 days
re-hospitalization
Time frame: 30 days
re- hospitalisation for Hemorrhagic recurrence is defined by recurrence of hematemesis, melena or rectal bleeding after discharge from hospital within 30 days
All cause mortality
Time frame: 30 days
The primary outcome was all-cause in-hospital mortality rate
comparaison with the glasgow blatchford score
Time frame: 30 days
comparaison with the glasgow blatchford score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: Undecided. after publication of the article
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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.
Riadh Boukef, professor principal investigator
CHU Sahloul, Emergency department, sousse
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 Bleeding, 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 26 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
re-bleeding (time frame: 30 days). The study lists 4 primary outcomes in all. 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 26 Jan 2023; AzTrials last refreshed its copy on 1 Nov 2026.