Platelet Inhibitor Treated Patients With Head Injury Trauma Without Any Clinical Symptoms of Cerebral Haemorrhage (NICE Criteria) : is the CT-scan Mandatory ?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,200
- 试验地点
- 13
- 主要终点
- Existence of a cerebral haemorrhage at the CT-scanner.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Absence of CT-scanner
- •Patients with double anti-platelet aggregation
- •Patients on anticoagulants
研究组 & 干预措施
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.
干预措施: CT-scanner (Radiation)
结局指标
主要结局
Existence of a cerebral haemorrhage at the CT-scanner.
时间窗: 1 day
Cerebral haemorrhage seen at the CT-scanner.
次要结局
- 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)