Clinical trial NCT03687528: Platelet Inhibitor Treated Patients with Head Injury Trauma Meeting NICE Criteria : is the CT-scan Mandatory ?
Official title: Platelet Inhibitor Treated Patients with Head Injury Trauma Without Any Clinical Symptoms of Cerebral Haemorrhage (NICE Criteria) : is the CT-scan Mandatory ?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head Injury Trauma
Emergencies
Keywords: emergencies
platelet inhibitors
minor head injury trauma
CT-scan
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 3200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major patients undergoing antiplatelet inhibitors treatment which are reported at the clinical exam as having a head injury trauma.

These patients don't meet another NICE criteria :

* neurological focal deficit
* amnesia for more than 30 min
* glasgow score less than 15 after 2 hours
* loss of consciousness associated with either a high velocity or an age \> 65 years old
* suspicion of a cranial open fracture
* fracture on cranial basis
* more than 1 vomit
* post-traumatic convulsion

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.

Detailed description: Head injuries are a frequent reason for emergency services, and according to studies, they represent between 5% and 10% of patients treated in emergencies. Among them, 90% are minor head injury traumas. NICE criteria has been defined to establish patients who need a CT-scanner because of a risk of cerebral haemorrhage.

NICE criteria include several conditions including taking antiplatelet inhibitors. However, the real risk of cerebral haemorrhage for theses cases is controversial in litterature. In parallel, more and more patients undergoing antiplatelet inhibitor's treatment are seen in emergencies after a head injury trauma.

In routine protocol at the emergency rooms, these patients are seen for a clinical exam and next submitted to a CT-scanner. If the clinician can't detect a cerebral haemorrage, the patient will return at home.

This study aims to determine that the absence of no other NICE criteria than antiplatelet inhibitors treatment 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.

This is a diagnostic, case-only, prospective, multicenter study with a blinded primary outcome measure assessment.

As described in routine protocol, in this study antiplatelet inhibitor's patients with head injury trauma will be seen for a clinical exam and next submitted to a CT-scanner. After a month, patient will be called by the clinical center to ask about morbidity and mortality. Especially, clinicans will report on the emergence of a cerebral haemorrhage during this month.

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

Primary outcomes:
measure: Existence of a cerebral haemorrhage at the CT-scanner.
timeFrame: 1 day
Secondary outcomes:
measure: Neurosurgeries' rate after one month
timeFrame: 1 month
measure: Existence of a cerebral haemorrhage associated to death
timeFrame: 1 month
measure: Existence of a cerebral haemorrhage associated to neurosurgery
timeFrame: 1 month
measure: Existence of a cerebral haemorrhage associated to hospitalization with more than 24h of intubation
timeFrame: 1 month
measure: Existence of a cerebral haemorrhage associated to more than 2 nights at hospital
timeFrame: 1 month
measure: Death rate after one month
timeFrame: 1 month
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Brest
country: France
facility: CHU Brest
city: Chartres
country: France
facility: CH Chartres
city: Le Mans
country: France
facility: CH Le Mans
city: Lorient
country: France
facility: CH Bretagne Sud, Lorient
city: Nantes
country: France
facility: CHU de Nantes
city: Poitiers
country: France
facility: CHU de Poitiers
city: Quimperlé
country: France
facility: CH Bretagne Sud - Quimperlé
city: Rennes
country: France
facility: CHU de Rennes
city: Saint-Brieuc
country: France
facility: CH de Saint Brieuc
city: Saint-Malo
country: France
facility: CH de Saint Malo
city: Vannes
country: France
facility: CH Bretagne Atlantique
Study officials:
affiliation: CHU Rennes
name: Paul-Georges REUTER, Pr
role: STUDY_DIRECTOR
References: