Patients With Upper Gastrointestinal Bleeding in Emergency Department

NCT05927493 | Completed

• 1 other identifier: 21-0034
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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. 1.to describe the characteristics of patients hospitalized for UGIB after their visit to the ED
2. 2.to assess the predictive factors of hospital intervention or death
3. 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. 4.Depending on the results, a new score could be derived to identify patients at low risk for intervention or death.

Conditions

Upper Gastrointestinal Bleeding

Keywords

Upper gastrointestinal bleeding; Emergency department; Low-risk; Scores

Outcome Measures

Primary Outcomes (2)

• Number of patients treated with specific therapeutic intervention

  Blood transfusion or endoscopic hemostasis or radiological hemostasis or surgical hemostasis in 7 days

  7 days

• Number of deceased patients

  30 days

Secondary Outcomes (5)

• Number of patients treated with blood transfusion(s)

  7 days

• Number of patients treated with endoscopic hemostasis

  7 days

• number of patients treated with endoscopic hemostasis

  7 days

• number of patients treated with interventional radiology hemostasis

  7 days

• Death

  30 days

Study Arms (1)

Upper gastrointestinal bleeding

Patients with upper gastrointestinal bleeding hospitalized after ED visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• reason for consultation not related to upper gastrointestinal bleeding (identified by manual reading of hospital notes)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Emergency department:Saint-Antoine Hospital

Paris, 75012, France

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Emergencies

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Pierre-Clément THIEBAUD, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: July 3, 2023
• Study Start: January 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

FR (1)