PHANTOM-S: The Pre-Hospital Acute Neurological Therapy and Optimization of Medical Care in Stroke Patients - Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 614
- 试验地点
- 1
- 主要终点
- alarm-to-needle time
研究概览
简要总结
The purpose of this prospective study in acute ischemic stroke patients is to compare alarm-to-needle time during randomly allocated periods with and without availability of a specially staffed ambulance equipped with computed tomography (CT) and point-of care diagnostics. The investigators hypothesize that compared to regular care the investigators will reduce alarm-to-needle time by a minimum of 20 minutes by implementation of the stroke emergency mobile unit.
详细描述
Time from symptom onset is crucial for the effectiveness of intravenous thrombolysis in acute ischemic stroke patients. Many patients receive tissue Plasminogen Activator (tPA) with considerable delay. The investigators developed an ambulance equipped with a CT-scanner, point-of-care laboratory, teleradiological support and an emergency trained neurologist on board. In the Pre-Hospital Acute Neurological Therapy and Optimization of Medical care in Stroke patients (PHANTOM-S)-study the investigators aim at a reduction of the current alarm-to-needle time by pre-hospital use of tissue Plasminogen Activator in an ambulance.
The investigators hypothesize that compared to regular care we will reduce alarm-to-needle time by a minimum of 20 minutes by implementation of the stroke emergency mobile unit (STEMO).
This is a prospective study comparing randomly allocated periods with and without STEMO availability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients whose emergency call prompted the suspicion of stroke within 4 hours of symptom onset or with undetermined time of onset in the dispatch center
- •Informed consent for documentation and follow-up provided by patients or legal representatives
排除标准
- •age < 18 years
- •pregnancy
研究组 & 干预措施
Regular Care
Regular care for suspected stroke in Berlin consists of an ambulance with paramedics only, and neither computed tomography (CT) nor point-of-care diagnostics. In Berlin, emergency physicians are involved in prehospital care only in cases of special medical emergencies such as severe instability of vital parameters or loss of consciousness.
Stroke Emergency Unit Mobile (STEMO)
The STEMO is equipped with a CT-scanner, a point-of-care laboratory and the infrastructure for tele-radiological as well as videoconferencing support. STEMO is operated by a team of experienced neurologists (n=6, half-time positions, with additional formal training in emergency medicine according to the requirements of the Berlin Medical Board), paramedics of the fire brigade (n=3, two years formal training in emergency care) and radiology technicians (n=3, three years formal training in radiology assistance and three months formal training in emergency care).
干预措施: Stroke Emergency Mobile Unit (STEMO) (Other)
结局指标
主要结局
alarm-to-needle time
时间窗: day 1
Primary endpoint of the study is the time between activation of the emergency medical service and initiation of thrombolysis (alarm-to-needle time).
次要结局
- Proportion of stroke patients receiving tissue Plasminogen Activator (tPA)(day 1)
- Functional outcomes(three months after symptom onset)
- Serious adverse events(up to 3 months)
- Mortality(up to three months)
- Costs effectiveness will be assessed(15 months (coinciding with the anticipated date of the completion of the last follow-up))
- symptomatic intracerebral hemorrhage(36 hours after symptom onset)
- Special referral(day 1)
- other times(day 1)