Platelet Inhibitor Treated Patients With Head Injury Trauma Meeting NICE Criteria : is the CT-scan Mandatory ?

NCT03687528 · tracked via the Priya Life Science France tracker

Sponsor

Rennes University Hospital

Phase

Observational

Started

2020-06-15

Last updated

2026-01-05

Condition(s) studied

Head Injury TraumaEmergencies

Investigational drug(s) / intervention(s)

CT-scanner

CT-scanner: After a clinical exam, patient have a CT-scanner to check any cerebral haemorrhage.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Existence of a cerebral haemorrhage at the CT-scanner. — 1 day
Cerebral haemorrhage seen at the CT-scanner.

Trial sites (12)

Facility	City	Region	Status
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03687528 on ClinicalTrials.gov ↗ ← All trials in France