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Clinical Trials/NCT04436575
NCT04436575
Unknown
Not Applicable

Interest of Clinical Ultrasound in Patients Consulting for Acute Gastrointestinal Bleeding in the Emergency Department: an Observational Monocentric Study

SUD Association pour le Développement de la Recherche et de lEnseignement1 site in 1 country150 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Gastrointestinal Bleeding
Sponsor
SUD Association pour le Développement de la Recherche et de lEnseignement
Enrollment
150
Locations
1
Primary Endpoint
Correlation of ultrasound parameters with the occurrence of adverse events
Last Updated
5 years ago

Overview

Brief Summary

Acute Gastrointestinal (GI) Bleeding are a common chief complaint among Emergency Department. The mortality rate for Lower GI Bleeding is 3.9%. While the mortality rate can be as high as 10% for Upper GI Bleeding. Most existing scores take into account hemodynamic parameters such as systolic blood pressure or heart rate. Studies have shown that hemodynamic instability only develops late in the course of a bleed, as evidenced by a blood depletion of 30 to 40% of the total blood volume. Currently, few studies have examined the value of echocardiography in the management of patients presenting for Acute GI Bleeding in the Emergency Department. The main objective of this study is to show whether simple ultrasound parameters can, combined with clinico biological parameters, predict in an early manner the evolution of the patient presenting to the Emergency Department for Acute Gastrointestinal Bleeding.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
November 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
SUD Association pour le Développement de la Recherche et de lEnseignement
Responsible Party
Principal Investigator
Principal Investigator

Thibaut MARKARIAN

Principal Investigator

SUD Association pour le Développement de la Recherche et de lEnseignement

Eligibility Criteria

Inclusion Criteria

  • Primary reason for emergency Department admission is acute gastrointestinal bleeding

Exclusion Criteria

  • Pregnant or breastfeeding women
  • Persons not benefiting from a social security scheme
  • Persons deprived of liberty
  • Patient participates in another study
  • The patient is in a period of exclusion determined by a previous study.
  • The patient is under legal protection, guardianship or trusteeship.
  • Patient refuses to participate
  • It proves impossible to give informed information about the subject matter
  • The patient is not fluent in French.

Outcomes

Primary Outcomes

Correlation of ultrasound parameters with the occurrence of adverse events

Time Frame: 1 day

The primary outcome was to determine the correlation of echocardiography parameters to detect adverse events (AEs). Echocardiography parameters included signs of severe hypovolemia (end systolic left ventricular obliteration and/or complete inspiratory collapse of the inferior vena cava and/or E velocity \< 0.7 m/s). Adverse events were defined as blood transfusion, therapeutic intervention to control haemorrhage (endoscopic, radiologic or surgical hemostasis), rebleeding and in-hospital mortality.

Secondary Outcomes

  • Other ultrasound parameters with the occurrence of adverse events(1 day)
  • Echocardiography and clinical scores(1 day)

Study Sites (1)

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