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Completed

NCT Number: NCT05927493

Patients With Upper Gastrointestinal Bleeding in Emergency Department

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.

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Key information

Conditions

Upper Gastrointestinal Bleeding Digestive System Diseases Disease Attributes Emergencies Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency department:Saint-Antoine Hospital

Paris, 75012, France

About this study

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:

  • to describe the characteristics of patients hospitalized for UGIB after their visit to the ED
  • to assess the predictive factors of death or therapeutic intervention (i.e, blood transfusion, endoscopic hemostasis, surgery or interventional radiology)
  • 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.
  • Depending on the results, a new score could be derived to identify patients at low risk for intervention or death.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Number of patients treated with specific therapeutic intervention

    Time frame: 7 days

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

  2. Number of deceased patients

    Time frame: 30 days

Secondary outcomes

  1. Number of patients treated with blood transfusion(s)

    Time frame: 7 days

    Transfusion of at least 1 red blood cell unit

  2. Number of patients treated with endoscopic hemostasis

    Time frame: 7 days

    Any hemostasis technique used during upper gastrointestinal endoscopy

  3. number of patients treated with endoscopic hemostasis

    Time frame: 7 days

    Arterioembolization or transjugular intrahepatic portosystemic shunt placement

  4. number of patients treated with interventional radiology hemostasis

    Time frame: 7 days

    Any hemostasis technique used during surgery

  5. Death

    Time frame: 30 days

    Intrahospital death

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: UGIB-ED

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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