Point-of-care Ultrasound Interest in Acute Gastrointestinal Bleeding Emergency Department Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Gastrointestinal Bleeding
• Intervention / Treatment: Device: Point-of-care ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • MARKARIAN Thibaut
    • Contact: Thibaut Markarian, MD; Phone Number: +33413429732; Email: thibaut.markarian@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients managed in investigative emergency department whose primary reason for management is acute gastrointestinal bleeding may be included. Patients with echocardiography are included.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of ultrasound parameters with the occurrence of adverse events	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiography and clinical scores	Correlation of echocardiographic 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) with existing clinical scores (Glasgow-Blatchford bleeding score and Rockall score). The Glasgow-Blatchford bleeding score includes measurements of hemoglobin in grams per deciliter, blood urea nitrogen in millimoles per liter, initial systolic blood pressure in millimeters of mercury, sex, heart rate in beats per minute, melena present, recent syncope, hepatic disease history and cardiac failure present. The Rockall score includes measurement of age, shock present, comorbidities, diagnosis and major stigmata of recent hemorrhage.	1 day
Other ultrasound parameters with the occurrence of adverse events	The correlation of other echocardiography parameters (visual assess of the ejection fraction (in percentage) and E/A ratio (represents the ratio of peak velocity blood flow from left ventricular relaxation in early diastole = the E velocity in meter per second, to peak velocity flow in late diastole caused by atrial contraction = the A velocity in meter per second) and E' velocity (in centimeter per seconds) and ratio E/E' (ratio between early mitral inflow velocity = the E velocity in centimeter per second and mitral annular early diastolic velocity = the E' velocity in centimeter per second) and subaortic velocity time index (VTI in centimeter) with the occurrence of adverse events.	1 day

Collaborators and Investigators

• Sponsor: SUD Association pour le Développement de la Recherche et de lEnseignement

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: echocardiography; emergency department; acute gastrointestinal bleeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Emergencies; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: TMarkarian/Ecuhda

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No