CClinicalTrials.gg
Status unknownNCT04436575Updated Jun 18, 2020

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

An observational study in Acute Gastrointestinal Bleeding, sponsored by SUD Association pour le Développement de la Recherche et de lEnseignement. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-18.

Sponsored by SUD Association pour le Développement de la Recherche et de lEnseignement · Observational

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Acute Gastrointestinal Bleeding

Keywords

  • emergency department
  • acute gastrointestinal bleeding
  • echocardiography
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In context

Gastrointestinal Hemorrhage

339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.

This study's planned enrollment of 150 is below the median of 200 across 116 observational studies indexed under Gastrointestinal Hemorrhage.

Browse Gastrointestinal Hemorrhage studies →

Lead sponsor

This is the only study on the registry with SUD Association pour le Développement de la Recherche et de lEnseignement as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Primary reason for emergency Department admission is acute gastrointestinal bleeding

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Interventions

  • DevicePoint-of-care ultrasound

    Point-of-care ultrasound prognostic performance : echocardiography mainly

    Also known as: Echocardiography

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

Secondary outcomes

  1. 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.

    Time frame: 1 day

  2. 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.

    Time frame: 1 day

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04436575
Lead sponsor
SUD Association pour le Développement de la Recherche et de lEnseignement
Responsible party
Thibaut MARKARIAN (Principal Investigator, SUD Association pour le Développement de la Recherche et de lEnseignement) — Principal investigator
First posted
Jun 18, 2020
Start date
Jul 1, 2020 (estimated)
Primary completion
Jul 1, 2021 (estimated)
Completion
Nov 1, 2021 (estimated)
Last update
Jun 18, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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