Clinical trial NCT05927493: Patients With Upper Gastrointestinal Bleeding in Emergency Department
Official title: Analysis of the Outcome of Patients With Suspected Upper GI Bleeding Managed in Emergency Departments in Ile de France and External Validation of Prognostic Scores
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Gastrointestinal Bleeding
Keywords: Upper gastrointestinal bleeding
Emergency department
Low-risk
Scores
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient ≥ 18 years old with a diagnosis of upper gastrointestinal bleeding hospitalized after an ED visit in hospital with data available in the Assistance Publique-Hôpitaux de Paris data warehouse

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of patients treated with specific therapeutic intervention
timeFrame: 7 days
measure: Number of deceased patients
timeFrame: 30 days
Secondary outcomes:
measure: Number of patients treated with blood transfusion(s)
timeFrame: 7 days
measure: Number of patients treated with endoscopic hemostasis
timeFrame: 7 days
measure: number of patients treated with endoscopic hemostasis
timeFrame: 7 days
measure: number of patients treated with interventional radiology hemostasis
timeFrame: 7 days
measure: Death
timeFrame: 30 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Emergency department:Saint-Antoine Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pierre-Clément THIEBAUD, MD
role: PRINCIPAL_INVESTIGATOR
References: