Acute Gastrointestinal BleedingNCT04436575
Point-of-care Ultrasound Interest in Acute Gastrointestinal Bleeding Emergency Department Patients
An observational study of Acute Gastrointestinal Bleeding, run by SUD Association pour le Développement de la Recherche et de lEnseignement at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Gastrointestinal Bleeding
- What is being tested?
- Point-of-care ultrasound
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Primary reason for emergency Department admission is acute gastrointestinal bleeding
Who cannot join
- 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.
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- Patient refuses to participate
- It proves impossible to give informed information about the subject matter
- The patient is not fluent in French.
Trial locations and contacts
1 site in 1 country.
France1 site
MARKARIAN Thibaut
Marseille
Thibaut Markarian, MD, +33413429732, thibaut.markarian@ap-hm.fr
About this study
Official title: 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.
- Conditions
- Acute Gastrointestinal Bleeding
- Being tested
- Point-of-care ultrasound
- Keywords
- emergency department, acute gastrointestinal bleeding, echocardiography
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care ultrasoundDevice
Also called Echocardiography
Point-of-care ultrasound prognostic performance : echocardiography mainly
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SUD Association pour le Développement de la Recherche et de lEnseignement
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thibaut MARKARIAN, SUD Association pour le Développement de la Recherche et de lEnseignement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436575
- Sponsor's protocol ID
- TMarkarian/Ecuhda
- Status last verified
- Jun 2020
- First submitted
- 21 May 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Clinical Ultrasound in Patients Consulting for Acute Gastrointestinal Bleeding in the Emergency Department: an Observational Monocentric Study
- ClinicalTrials.gov ID
- NCT04436575
- Acronym / sponsor ID
- TMarkarian/Ecuhda
- Conditions
- Acute Gastrointestinal Bleeding
- Keywords
- emergency department, acute gastrointestinal bleeding, echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- SUD Association pour le Développement de la Recherche et de lEnseignementUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Primary reason for emergency Department admission is acute gastrointestinal bleeding
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care ultrasoundAlso: EchocardiographyPoint-of-care ultrasound prognostic performance : echocardiography mainly | Device | – |
Primary outcome
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.
2 secondary outcomes
Echocardiography and clinical scores
Time frame: 1 day
Other ultrasound parameters with the occurrence of adverse events
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Gastrointestinal Bleeding, run by SUD Association pour le Développement de la Recherche et de lEnseignement at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of ultrasound parameters with the occurrence of adverse events (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.