Clinical-biological Score for Upper Gastrointestinal Bleeding

Sponsor
Hôpital Universitaire Sahloul (Other)
Overall Status
Completed
CT.gov ID
NCT05688501
Collaborator
(none)
150
1
36
4.2

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • Other: descriptiv group

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

Study Type:
Observational
Actual Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Sep 1, 2022
Actual Study Completion Date :
Sep 1, 2022

Outcome Measures

Primary Outcome Measures

  1. re-bleeding [30 days]

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

  2. re-hospitalization [30 days]

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

  3. All cause mortality [30 days]

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

  4. comparaison with the glasgow blatchford score [30 days]

    comparaison with the glasgow blatchford score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • 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;
Exclusion Criteria:
  • patient under the age of 18

  • diagnosis of external hemorrhoids / perianal lesions

  • Not consenting

  • The lost sight

Contacts and Locations

Locations

Site City State Country Postal Code
1 HU Sahloul, sousse, Tunisia Sousse Itinéraire Ceinture Cité Sahloul Tunisia 4054

Sponsors and Collaborators

  • Hôpital Universitaire Sahloul

Investigators

  • Principal Investigator: Riadh Boukef, professor, CHU Sahloul, Emergency department, sousse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riadh Boukef, Professor, Hôpital Universitaire Sahloul
ClinicalTrials.gov Identifier:
NCT05688501
Other Study ID Numbers:
  • GIB-ED
First Posted:
Jan 18, 2023
Last Update Posted:
Jan 26, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2023