Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05927493 |
| Other study ID # |
21-0034 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2019 |
| Est. completion date |
February 1, 2021 |
Study information
| Verified date |
June 2023 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
