Evaluating the necessity of CT-scans for head injury patients on platelet inhibitors
Official title: Platelet Inhibitor Treated Patients With Head Injury Trauma Without Any Clinical Symptoms of Cerebral Haemorrhage (NICE Criteria) : is the CT-scan Mandatory ?
Run by Rennes University Hospital · NCT03687528 · Data updated 2026-11-12
This study is testing if patients with minor head injuries who are on blood-thinning medications really need a CT-scan to check for bleeding in the brain.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3200 (estimated) |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 12 sites (Angers and 11 other locations) |
| Status | Recruiting |
| Started | June 15, 2020 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT03687528 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who have experienced a head injury and are currently on antiplatelet inhibitors.
✕Probably not a fit
Patients who are on anticoagulants or have double anti-platelet aggregation will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates whether patients with head injuries who are treated with antiplatelet inhibitors require a CT-scan to rule out cerebral hemorrhage. It focuses on patients meeting NICE criteria, specifically those with minor head injuries, to assess if the presence of antiplatelet treatment alone is sufficient to eliminate the risk of hemorrhage. The study employs a prospective, multicenter design with blinded outcome assessments, aiming to clarify the current clinical protocol in emergency settings. By analyzing the outcomes of these patients, the study seeks to provide evidence that could potentially change the standard practice regarding CT-scan usage in this population.
Why it matters
Potential benefit: If successful, this study could reduce unnecessary CT-scans for patients with minor head injuries on antiplatelet therapy, minimizing radiation exposure and healthcare costs.
How similar studies have gone: While there is ongoing debate in the literature regarding the necessity of CT-scans for this patient group, this study aims to provide new insights, suggesting that it is a novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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CHU d'Angers
Angers, France Recruiting -
CHU Brest
Brest, France Recruiting -
CH Chartres
Chartres, France Recruiting -
CH Le Mans
Le Mans, France Recruiting -
CH Bretagne Sud, Lorient
Lorient, France Recruiting -
CHU de Nantes
Nantes, France Recruiting
Show 6 more locations
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CHU de Poitiers
Poitiers, France Recruiting -
CH Bretagne Sud - Quimperlé
Quimperlé, France Recruiting -
CHU de Rennes
Rennes, France Recruiting -
CH de Saint Malo
St-Malo, France Recruiting -
CH de Saint Brieuc
Saint-Brieuc, France Not yet recruiting -
CH Bretagne Atlantique
Vannes, France Not yet recruiting
Study contacts
- Study coordinator: Paul-Georges REUTER, Pr
- Email: paul-georges.reuter@chu-rennes.fr
- Phone: +33 2 99 28 43 21
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.