Evaluating the necessity of CT-scans for head injury patients on platelet inhibitors
Platelet Inhibitor Treated Patients With Head Injury Trauma Without Any Clinical Symptoms of Cerebral Haemorrhage (NICE Criteria) : is the CT-scan Mandatory ?
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 |
|---|---|
| Enrollment | 3200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 12 sites (Angers and 11 other locations) |
| Trial ID | NCT03687528 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced a head injury and are currently on antiplatelet inhibitors.
Not a fit: Patients who are on anticoagulants or have double anti-platelet aggregation will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Angers and 11 other locations
- 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)
- CHU de Poitiers — Poitiers, France (Recruiting)
- CH Bretagne Sud - Quimperlé — Quimperlé, France (Recruiting)
- CHU de Rennes — Rennes, France (Recruiting)
- CH de Saint Brieuc — Saint-Brieuc, France (Not_yet_recruiting)
- CH de Saint Malo — St-Malo, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.