NCT03687528 Platelet Inhibitor Treated Patients With Head Injury Trauma Meeting NICE Criteria : is the CT-scan Mandatory ?
| NCT ID | NCT03687528 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rennes University Hospital |
| Condition | Head Injury Trauma |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,200 participants |
| Start Date | 2020-06-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,200 participants in total. It began in 2020-06-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
At the emergencies rooms, patients with head trauma meeting one of the NICE criteria, which include antiplatelet inhibitors treatment, are considered as patients with a risk of cerebral haemorrage and are taken systematically for a CT-scanner. However, there are more and more antiplatelet inhibitor's patient with minor head injury traumas seen at the emergencies room and the efficiency of this NICE criteria is controversial on litterature. This study aims to determine that the absence of no other NICE criteria than antiplatelet inhibitors is a sufficient condition to eliminate a cerebral haemorrhage for patients with head injury traumas, and conversely, that antiplatelet inhibitors treatment would not be by itself an indication for a CT-scanner.
Eligibility Criteria
Inclusion Criteria: * At least 18 years old * Patient with a head injury trauma, described by the patient or seen at the clinical exam * Glasgow score between 13 and 15 at the clinical exam * Current treatment with antiplatelet inhibitors * Informed non opposition form signed Exclusion Criteria : * Absence of CT-scanner * Patients with double anti-platelet aggregation * Patients on anticoagulants
Contact & Investigator
Paul-Georges REUTER, Pr
STUDY DIRECTOR
Rennes University Hospital
Frequently Asked Questions
Who can join the NCT03687528 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head Injury Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03687528 currently recruiting?
Yes, NCT03687528 is actively recruiting participants. Contact the research team at paul-georges.reuter@chu-rennes.fr for enrollment information.
Where is the NCT03687528 trial being conducted?
This trial is being conducted at Angers, France, Brest, France, Chartres, France, Le Mans, France and 8 additional locations.
Who is sponsoring the NCT03687528 clinical trial?
NCT03687528 is sponsored by Rennes University Hospital. The principal investigator is Paul-Georges REUTER, Pr at Rennes University Hospital. The trial plans to enroll 3,200 participants.