NCT05688501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

November 29, 2022

Last Update Submit

January 23, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • re-bleeding

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

    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

    30 days

  • All cause mortality

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

    30 days

  • comparaison with the glasgow blatchford score

    comparaison with the glasgow blatchford score

    30 days

Interventions

no intervention

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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;

You may not qualify if:

  • patient under the age of 18
  • diagnosis of external hemorrhoids / perianal lesions
  • Not consenting
  • The lost sight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HU Sahloul, sousse, Tunisia

Sousse, Itinéraire Ceinture Cité Sahloul, 4054, Tunisia

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Riadh Boukef, professor

    CHU Sahloul, Emergency department, sousse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2022

First Posted

January 18, 2023

Study Start

September 1, 2019

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations