UGIB-ED: Patients With Upper Gastrointestinal Bleeding in Emergency Department

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT05927493
Collaborator
(none)
2,000
1
25
79.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Jan 1, 2019
    Actual Primary Completion Date :
    Feb 1, 2021
    Actual Study Completion Date :
    Feb 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Upper gastrointestinal bleeding

    Patients with upper gastrointestinal bleeding hospitalized after ED visit

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients treated with specific therapeutic intervention [7 days]

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

    2. Number of deceased patients [30 days]

    Secondary Outcome Measures

    1. Number of patients treated with blood transfusion(s) [7 days]

      Transfusion of at least 1 red blood cell unit

    2. Number of patients treated with endoscopic hemostasis [7 days]

      Any hemostasis technique used during upper gastrointestinal endoscopy

    3. number of patients treated with endoscopic hemostasis [7 days]

      Arterioembolization or transjugular intrahepatic portosystemic shunt placement

    4. number of patients treated with interventional radiology hemostasis [7 days]

      Any hemostasis technique used during surgery

    5. Death [30 days]

      Intrahospital death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emergency department:Saint-Antoine Hospital Paris France 75012

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Pierre-Clément THIEBAUD, MD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT05927493
    Other Study ID Numbers:
    • 21-0034
    First Posted:
    Jul 3, 2023
    Last Update Posted:
    Jul 3, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 3, 2023