A Reduction in Time With Electronic Monitoring In Stroke (ARTEMIS) Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- total system delay (TSD) to intravenous thrombolysis (IVT)
研究概览
简要总结
The purpose of the ARTEMIS trial is to investigate if real-time feedback to caregivers reduces the time between patient's first medical contact and start of intravenous thrombolysis and/or intraarterial thrombectomy in patients with acute ischemic stroke.
详细描述
Background
For the clinical benefit of intravenous thrombolysis (IVT) and intra-arterial thrombectomy (IAT) time is the most crucial factor. Reducing the time between stroke onset and treatment is therefore a major goal in acute stroke care. The delay from first moment the Emergency Medical Services (EMS) dispatch office is alarmed and initiation of treatment (IVT and/or IAT), i.e. 'total system delay' (TSD), depends greatly on logistics and collaboration between various caregivers in this trajectory. A promising method to improve workflow and thereby aiming to reduce TSD is to provide real-time audio-visual feedback to caregivers.
Methods
The A Reduction in Time with Electronic Monitoring In Stroke (ARTEMIS) trial is a multiregional, multicenter, prospective randomized open end-point trial to investigate the intervention of real-time audio-visual feedback to caregivers reduces TSD to IVT/IAT.
The intervention compromises real-time audio-visual feedback to caregivers on actual treatment delay for each individual patient. Randomization of real-time audio-visual feedback will be automatically generated per patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •all patients older than 18 years that are considered potentially eligible for IVT/IAT by the dispatch office, following regional EMS' standard stroke algorithm.
排除标准
- •age < 18 years
结局指标
主要结局
total system delay (TSD) to intravenous thrombolysis (IVT)
时间窗: 4.5 hours after symptom onset
total system delay (TSD) to intraarterial thrombectomy (IAT)
时间窗: 6 hours after symptom onset
次要结局
- number of patients eventually treated with intravenous thrombolysis (IVT) and/or intraarterial thrombectomy (IAT)(through study completion, an average of 2 years)
- symptomatic intracerebral haematoma (ICH)(90 days after treatment (IVT/IAT))
- functional outcome / modified Rankin Scale (mRS)(90 days after treatment (IVT/IAT))
- proportion of stroke mimics treated with intravenous thrombolysis (IVT) or intraarterial thrombectomy (IAT)(through study completion, an average of 2 years)
- differences between regions (urban/periferal)(through study completion, an average of 2 years)
研究者
NyikaKruyt
N.D. Kruyt, PhD, Neurologist
Leiden University Medical Center