An observational study in Gastro Intestinal Bleed, sponsored by Hôpital Universitaire Sahloul. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by Hôpital Universitaire Sahloul · Observational
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We have developed a new reliable, easy and reproducible clinical and biological score to select patients presenting to the emergency department with upper GI bleeding and at high risk of developing complications in order to plan an adequate management.
This score was compared to the Glasgow-Blatchford score and showed better results in predicting rebleeding, the need for hemostasis therapy and any complications at day 30 including mortality.
In a second step and as an objective of this study, it is necessary to perform an external validation of this score in different emergency departments.
We have developed a new reliable, easy and reproducible clinical and biological score to select patients presenting to the emergency department with upper GI bleeding and at high risk of developing complications in order to plan an adequate management.
This score was compared to the Glasgow-Blatchford score and showed better results in predicting rebleeding, the need for hemostasis therapy and any complications at day 30 including mortality.
In a second step and as an objective of this study, it is necessary to perform an external validation of this score in different emergency departments.
We will conduct a multicenter, descriptive and analytical study in different emergency departments Inclusion criteria: patients consulting the emergency department for upper GI hemorrhage of non-traumatic origin.
Exclusion criteria: patients under 18 years of age, diagnosed with external hemorrhoids with parietal lesions. We exclude any patient who does not consent, is lost to follow-up or has incomplete information.
Anonymity and confidentiality of the data were respected. Data collection was carried out using a data processing form designed for the purpose of this work, including descriptive analysis of the epidemiological and clinical characteristics of the patients, as well as the para-clinical data.
Patients were followed up by telephone call at D30 to record the date and cause of any complications noted, such as rebleeding, hospitalization, or death.
The data will be entered and analyzed in SPSS 21.0
338 studies on the registry are indexed under Gastrointestinal Hemorrhage; 77 are open to participants now.
This study's planned enrollment of 500 is above the median of 176 across 117 observational studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Hôpital Universitaire Sahloul is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
multicentric, descriptive and analytical study in different emergency departments
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Exclusion Criteria:
The primary outcome was all-cause in-hospital mortality rate
The primary outcome was all-cause in-hospital mortality rate
Time frame: 30 days after inclusion
re-bleeding, re-hospitalization, discharge
Hemorrhagic recurrence is defined by recurrence of hematemesis, melena or rectal bleeding after discharge from hospital within 30 days
Time frame: 30 days after inclusion
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Dec 2023, 5 months after the start.
Of 42 non-industry observational studies under Gastrointestinal Hemorrhage, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 63. This study's planned 5 months is below that.
Counting every sponsor, half of 47 studies reached it within 36 months; a quarter within 23 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
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Hôpital Universitaire Sahloul