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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05589103
Other study ID # 7409
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2022

Study information

Verified date October 2022
Source University Hospital, Strasbourg, France
Contact Florent BAICRY, MD
Phone 33 3 69 55 03 86
Email florent.baicry@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1692
Est. completion date December 31, 2022
Est. primary completion date December 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria - 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 - Subject under safeguard of justice - Subject under guardianship or curatorship - Patient on anticoagulant - Non-isolated head trauma (AVP, fall greater than 6 meters, etc.)

Study Design


Locations

Country Name City State
France Service d'accueil des urgences - CHU de Strasbourg - France Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Propensity score on the factors influencing the taking of antiplatelet agents. Files analysed retrospectively from January 01, 2017 to December 31, 2017 will be examined
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