Platelet Inhibitor Treated Patients With Head Injury Trauma Meeting NICE Criteria : is the CT-scan Mandatory ?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT-scanner.
- Who it may be relevant to
- Registry conditions: Head Injury Trauma, Emergencies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Platelet Inhibitor Treated Patients With Head Injury Trauma Without Any Clinical Symptoms of Cerebral Haemorrhage (NICE Criteria) : is the CT-scan Mandatory ?
Overview
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.
Interventions
- Radiation CT-scanner
After a clinical exam, patient have a CT-scanner to check any cerebral haemorrhage.
Primary outcome measures
- Existence of a cerebral haemorrhage at the CT-scanner. [Time frame: 1 day]
Secondary outcome measures (6)
- Neurosurgeries' rate after one month [Time frame: 1 month]
- Existence of a cerebral haemorrhage associated to death [Time frame: 1 month]
- Existence of a cerebral haemorrhage associated to neurosurgery [Time frame: 1 month]
- Existence of a cerebral haemorrhage associated to hospitalization with more than 24h of intubation [Time frame: 1 month]
- Existence of a cerebral haemorrhage associated to more than 2 nights at hospital [Time frame: 1 month]
- Death rate after one month [Time frame: 1 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 12 centers
- CHU d'Angers — Angers
- CHU Brest — Brest
- CH Chartres — Chartres
- CH Le Mans — Le Mans
- CH Bretagne Sud, Lorient — Lorient
- CHU de Nantes — Nantes
- CHU de Poitiers — Poitiers
- CH Bretagne Sud - Quimperlé — Quimperlé
- … and 4 more centers
Identifiers
NCT: NCT03687528 · 35RC17_8839_T.CAP