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临床试验/NCT04617808
NCT04617808已完成不适用

Predictive Score for Non-traumatic Secondary Headache After an Emergency Call

Centre Hospitalier Régional d'Orléans2 个研究点 分布在 1 个国家目标入组 715 人开始时间: 2020年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
715
试验地点
2
主要终点
Proportion of patients with diagnosis of non-traumatic secondary headache

研究概览

简要总结

The study objective was to identify predictive criteria of severe non-traumatic secondary headache among the information gathered during telephone interview conducted by the on-call regulating physician at the Centre15.

详细描述

Headache accounted for 1% of outpatient consultations, 2% of hospital emergency department visits and, at the French national level, 1% of complaints motivating calls to the prehospital emergency medical service units (The French, physician-led Emergency Calls Centers , called either "Center 15" or Service d'Aide Médicale d'Urgence [SAMU]). In 2009, the French "SAMU-Urgences de France" society proposed a classification and diagnostic tool for evaluating the headache patient, which is yet to be validated by a clinical study. Most patients with headache spontaneously consulted the emergency department (ED) and only 4 to 5% of patients entered ED through ambulance, fire and rescue department, medicalized ambulance (SMUR), or police. Patients attending emergency service for unusual sudden headache arriving by ambulance had a higher frequency of subarachnoid haemorrhage.

Headache studies have mainly been conducted in the ED. The Ottawa rule published by Perry et al. in 2013 proposed criteria for conducting explorations for subarachnoid hemorrhage (SAH) in patients over 15 years of age with severe, non-traumatic headache, having reached maximum intensity within one hour.

Unlike the primary headaches, secondary headaches are associated with underlying causes. Among the severe secondary headaches (SSH) (4 to 5% of headaches), non-traumatic subarachnoid haemorrhage was not diagnosed in 5.4% to 12% of cases in ED resulting in increase in mortality from 5 to 14%.

In 2018, French guidelines for the emergency management of headache recognized criteria likely to be at risk of Severe Secondary Headache, requiring explorations in emergencies for sudden headaches or thunderclaps headaches (i.e. reaching maximum intensity in less than a minute), recent headaches or progressive worsening (<7 days) and unusual, association with fever (apart from an obvious cause), association with signs of neurological impairment, suspicion of carbon monoxide poisoning, immunosuppression (neoplasia, HIV). Any unusual headache in a patient with recurrent paroxysmal or chronic headache should be considered secondary until proven otherwise. Subarachnoid hemorrhages were present in 11% of patients with sudden, intense and unusual headache.

In the French department of Loiret, patients with subarachnoid haemorrhage required a transfer out of the department to the nearest regional referral teaching hospital, by lack of adequate equipment and expertise for interventional neurology. Early diagnosis was therefore critical. In fact, an untreated cerebral aneurysm rupture increased bleeding recurrence by 3-4% in the first 24 hours.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Telephone call from center 15 for the headache pattern
  • Non-opposition expressed by the patient
  • Or non-opposition delayed (adults with cognitive disorders, protected adults, clinical situations judged to be serious by the Medical Regulation Assistant, physician regulator, incoming call flow, call by close or trusted person)

排除标准

  • Head trauma < 48 hours
  • Moribund patient
  • Non-affiliation to a social security scheme
  • Opposition to the continuation of the study expressed orally by the patient or by return mail within 30 days

结局指标

主要结局

Proportion of patients with diagnosis of non-traumatic secondary headache

时间窗: Day 21

Proportion of patients with diagnosis of non-traumatic secondary headache attended by the French emergency services operating

次要结局

  • Proportion of patients requiring an admission to Intensive Care Unit(Day 2)
  • Number of patients with early mortality(Day 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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