Platelet Inhibitor Treated Patients With Head Injury Trauma Without Any Clinical Symptoms of Cerebral Haemorrhage (NICE Criteria) : is the CT-scan Mandatory ?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 3,200
- Locations
- 13
- Primary Endpoint
- Existence of a cerebral haemorrhage at the CT-scanner.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patient with minor head injury trauma
The emergency protocol for antiplatelet inhibitors treated patient with head injury trauma and meeting others NICE criteria involves a clinical exam followed by a CT-scanner.
Intervention: CT-scanner (Radiation)
Outcomes
Primary Outcomes
Existence of a cerebral haemorrhage at the CT-scanner.
Time Frame: 1 day
Cerebral haemorrhage seen at the CT-scanner.
Secondary Outcomes
- Existence of a cerebral haemorrhage associated to neurosurgery(1 month)
- Existence of a cerebral haemorrhage associated to more than 2 nights at hospital(1 month)
- Neurosurgeries' rate after one month(1 month)
- Existence of a cerebral haemorrhage associated to death(1 month)
- Death rate after one month(1 month)
- Existence of a cerebral haemorrhage associated to hospitalization with more than 24h of intubation(1 month)