Patients With Upper Gastrointestinal Bleeding in Emergency Department

NCT ID: NCT05927493

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-02-01

Brief Summary

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More than 80% of patients with upper gastrointestinal bleeding (UGIB) are hospitalized after their visit to the emergency department (ED). However, some of these hospitalizations do not seem justified. Several clinical scores have been developed to classify patients according to their risk of death or need for therapeutic intervention.

The aims of this study are:

1. to describe the characteristics of patients hospitalized for UGIB after their visit to the ED
2. to assess the predictive factors of hospital intervention or death
3. to assess the accuracy of existing prognostic scores to classify patients according their risk of death or need for therapeutic intervention (external validation) and to identify low-risk patients not requiring intervention.
4. Depending on the results, a new score could be derived to identify patients at low risk for intervention or death.

Detailed Description

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Upper gastrointestinal bleeding (UGIB) is caused by several conditions, with an overall mortality of approximately 10%. More than 80% of patients are hospitalized after their visit to the emergency department (ED) \[1\]. The hospitalization usually allows an etiological diagnosis to be made by performing an upper gastrointestinal endoscopy (UGE) and a hemostatic treatment if required. However, some of these hospitalizations do not seem justified. Indeed, some patients do not require any intervention (i.e., blood transfusion, endoscopic, radiological or surgical hemostasis) and have no complications (i.e., rebleeding, death). Some of them do not even have a diagnostic UGE during their hospital stay.

Several clinical scores have been developed to classify patients according their risk of death or need for therapeutic intervention, some of them to identify patients with low-risk of complications (rebleeding, death) and/or need for intervention. The most commonly known are the pre-endoscopic Rockall score, the Glasgow-Blatchford Score (GBS) and the AIMS65. Among them, the GBS seems to be the most efficient \[2,3\]. Its use is encouraged in the latest French, European and international recommendations \[4\].

Other prognostic scores have more recently been proposed with this purpose (e.g. modified GBS, CANUKA, H3B2, C-Watch, Harbinger), with interesting results but scarce or no external validation.

The aims of this study are:

1. to describe the characteristics of patients hospitalized for UGIB after their visit to the ED
2. to assess the predictive factors of death or therapeutic intervention (i.e, blood transfusion, endoscopic hemostasis, surgery or interventional radiology)
3. to assess the accuracy of existing prognostic scores to classify patients according their risk of death or need for therapeutic intervention (external validation) and to identify low-risk patients not requiring intervention.
4. Depending on the results, a new score could be derived to identify patients at low risk for intervention or death.

Conditions

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Upper Gastrointestinal Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Upper gastrointestinal bleeding

Patients with upper gastrointestinal bleeding hospitalized after ED visit

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patient ≥ 18 years old
* with a diagnosis of upper gastrointestinal bleeding (defined by ICD10 codes)
* visited a hospital with ED data available in the data warehouse

Exclusion Criteria

* reason for consultation not related to upper gastrointestinal bleeding (identified by manual reading of hospital notes)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-Clément THIEBAUD, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Emergency department:Saint-Antoine Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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21-0034

Identifier Type: -

Identifier Source: org_study_id

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