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

Acute Gastrointestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04436575
• Other study ID #: TMarkarian/Ecuhda
• Status: Not yet recruiting
• Start date: July 1, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: June 2020
• Source: SUD Association pour le Développement de la Recherche et de lEnseignement
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: November 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Gastrointestinal Bleeding
• Emergencies
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Device:
• Point-of-care ultrasound
Point-of-care ultrasound prognostic performance : echocardiography mainly

Locations

Country	Name	City	State
France	MARKARIAN Thibaut	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
SUD Association pour le Développement de la Recherche et de lEnseignement

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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