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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Tunisia

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.

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.

  1. re-bleeding

    Hemorrhagic recurrence is defined by recurrence of hematemesis, melena or rectal bleeding after discharge from hospital within 30 days

    Measured: 30 days

  2. 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

  3. All cause mortality

    The primary outcome was all-cause in-hospital mortality rate

    Measured: 30 days

  4. 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.

  1. First posted18 Jan 2023
  2. Study start1 Sep 2019
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2022

Resources

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)
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

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.

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