Head Trauma InjuryTrauma-HeadNCT05589103
Mild Head Trauma in the Emergency Room: Assessment of the Risk of Intracranial Hemorrhage in Patients Receving Platelet Inhibitors.
An observational study of Head Trauma Injury, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The clinical signs presented by a patient with a mild head injury are highly variable but remain strongly predictive of brain damage. The reference examination for the diagnosis of post-traumatic intracranial hemorrhage is currently the cerebral scanner without injection of contrast medium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Trauma Injury
- How many people
- 1,692 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 31 Dec 2022
- 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
- Adult, Older adult
Study population: Adult patient (≥18 years old) victim of mild head trauma visiting the emergency room of the Strasbourg University Hospital during 2017.
Who may be able to join
- Adult patient (≥18 years old)
- Visit to the emergency room of the Strasbourg University Hospital during 2017
- Victim of mild head trauma
- Patient who has given their consent to the reuse of their data for the purposes of this research.
- Non-inclusion criteria
- Patient who expressed their opposition to participating in the study
Show all 10Show fewer
- Subject under safeguard of justice
- Subject under guardianship or curatorship
- Patient on anticoagulant
- Non-isolated head trauma (AVP, fall greater than 6 meters, etc.)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'accueil des urgences - CHU de Strasbourg - France
Strasbourg, 67091
Florent BAICRY, MD, 33 3 69 55 03 86, florent.baicry@chru-strasbourg.fr
Florent BAICRY, MD
About this study
The clinical signs presented by a patient with a mild head injury are highly variable but remain strongly predictive of brain damage. The reference examination for the diagnosis of post-traumatic intracranial hemorrhage is currently the cerebral scanner without injection of contrast medium. Magnetic resonance imaging (MRI) tends to surpass CT in equipped centers, except for suspected bone lesions. The time required to perform brain imaging depends on the patient's clinical condition, comorbidities and treatments.
The responsibility of antiplatelet agents in post-traumatic intracranial hemorrhage is currently discussed, particularly with aspirin.
The hypothesis is that there is no significant difference in the proportion of intracranial hemorrhage in patients on antiplatelet agents after mild head trauma, in the absence of other factors favoring the occurrence of intracranial hemorrhage.
- Conditions
- Head Trauma Injury
- Keywords
- Head Trauma Injury, Head Trauma, Traumatic Intracranial Hemorrhage, Antiaggregants, Platelet
- Medical subject headings
- Craniocerebral Trauma, Intracranial Hemorrhage, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Propensity score on the factors influencing the taking of antiplatelet agents.
Measured: Files analysed retrospectively from January 01, 2017 to December 31, 2017 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Jan 2020
- Primary completionDec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Trauma InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,692 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589103
- Sponsor's protocol ID
- 7409
- Acronym
- Trauma-Head
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Head Trauma in the Emergency Room: Assessment of the Risk of Intracranial Hemorrhage in Patients Receving Platelet Inhibitors.
- ClinicalTrials.gov ID
- NCT05589103
- Acronym / sponsor ID
- Trauma-Head / 7409
- Conditions
- Head Trauma Injury
- Keywords
- Head Trauma Injury, Head Trauma, Traumatic Intracranial Hemorrhage, Antiaggregants, Platelet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,692 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Oct 2022 (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.
The clinical signs presented by a patient with a mild head injury are highly variable but remain strongly predictive of brain damage. The reference examination for the diagnosis of post-traumatic intracranial hemorrhage is currently the cerebral scanner without injection of contrast medium. Magnetic resonance imaging (MRI) tends to surpass CT in equipped centers, except for suspected bone lesions. The time required to perform brain imaging depends on the patient's clinical condition, comorbidities and treatments.
The responsibility of antiplatelet agents in post-traumatic intracranial hemorrhage is currently discussed, particularly with aspirin.
The hypothesis is that there is no significant difference in the proportion of intracranial hemorrhage in patients on antiplatelet agents after mild head trauma, in the absence of other factors favoring the occurrence of intracranial hemorrhage.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥18 years old) victim of mild head trauma visiting the emergency room of the Strasbourg University Hospital during 2017.
Key inclusion criteria (10 listed)
- Adult patient (≥18 years old)
- Visit to the emergency room of the Strasbourg University Hospital during 2017
- Victim of mild head trauma
- Patient who has given their consent to the reuse of their data for the purposes of this research.
- Non-inclusion criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Propensity score on the factors influencing the taking of antiplatelet agents.
Time frame: Files analysed retrospectively from January 01, 2017 to December 31, 2017 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
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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 Head Trauma Injury, run by University Hospital, Strasbourg, France 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 10 inclusion and 0 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 21 Oct 2022. 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?
Contact Florent BAICRY, MD (33 3 69 55 03 86, florent.baicry@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propensity score on the factors influencing the taking of antiplatelet agents. (time frame: Files analysed retrospectively from January 01, 2017 to December 31, 2017 will be examined). 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 21 Oct 2022.