Upper Gastrointestinal BleedingUGIB-EDNCT05927493
Patients With Upper Gastrointestinal Bleeding in Emergency Department
An observational study of Upper Gastrointestinal Bleeding, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 1 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- reason for consultation not related to upper gastrointestinal bleeding (identified by manual reading of hospital notes)
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- to describe the characteristics of patients hospitalized for UGIB after their visit to the ED
- to assess the predictive factors of hospital intervention or death
- 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.
Read the 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:
- 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.
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- Upper gastrointestinal bleeding, Emergency department, Low-risk, Scores
- Medical subject headings
- Gastrointestinal Hemorrhage, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Upper gastrointestinal bleeding | Patients with upper gastrointestinal bleeding hospitalized after ED visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients treated with specific therapeutic intervention
Blood transfusion or endoscopic hemostasis or radiological hemostasis or surgical hemostasis in 7 days
Measured: 7 days
Number of deceased patients
Measured: 30 days
Secondary outcomes (5)
Number of patients treated with blood transfusion(s)
Transfusion of at least 1 red blood cell unit
Measured: 7 days
Number of patients treated with endoscopic hemostasis
Any hemostasis technique used during upper gastrointestinal endoscopy
Measured: 7 days
number of patients treated with endoscopic hemostasis
Arterioembolization or transjugular intrahepatic portosystemic shunt placement
Measured: 7 days
number of patients treated with interventional radiology hemostasis
Any hemostasis technique used during surgery
Measured: 7 days
Death
Intrahospital death
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jan 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Clément THIEBAUD, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927493
- Sponsor's protocol ID
- 21-0034
- Acronym
- UGIB-ED
- Status last verified
- Jun 2023
- First submitted
- 11 May 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05927493
- Acronym / sponsor ID
- UGIB-ED / 21-0034
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- Upper gastrointestinal bleeding, Emergency department, Low-risk, Scores
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to describe the characteristics of patients hospitalized for UGIB after their visit to the ED
- to assess the predictive factors of hospital intervention or death
- 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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper gastrointestinal bleeding | – | –Patients with upper gastrointestinal bleeding hospitalized after ED visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- reason for consultation not related to upper gastrointestinal bleeding (identified by manual reading of hospital notes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Number of deceased patients
Time frame: 30 days
5 secondary outcomes
Number of patients treated with blood transfusion(s)
Time frame: 7 days
Number of patients treated with endoscopic hemostasis
Time frame: 7 days
number of patients treated with endoscopic hemostasis
Time frame: 7 days
number of patients treated with interventional radiology hemostasis
Time frame: 7 days
Death
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Clément THIEBAUD, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Gastrointestinal Bleeding, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients treated with specific therapeutic intervention (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.