Ambulance Stroke Triage Assisted by Telemedicine (ASTRAL) Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 484
- 试验地点
- 1
研究概览
简要总结
The ASTRAL trial is a randomized study in patients with suspected stroke in the ambulance setting. The study evaluates whether prehospital telestroke consultation, in addition to standard care, can reduce unnecessary stroke code activations and improve patient triage, treatment efficiency, and resource use. Participants are randomized to telestroke triage plus standard care or standard care alone. Outcomes include unnecessary stroke code activation, patient allocation, treatment times, functional outcome, safety, and cost-effectiveness.
详细描述
The Ambulance Stroke Triage Assisted by Telemedicine (ASTRAL) trial is a prospective, randomized controlled trial in suspected stroke patients attended by ambulance professionals in the RAV Hollands Midden region. Patients aged 18 years or older with stroke code activation during office hours and symptom onset within 24 hours are randomized 1:1 to telestroke triage plus standard care or standard care alone. The intervention consists of real-time video and audio consultation with an on-duty neurologist who advises on stroke probability, destination, and urgency of transport, while ambulance professionals retain final decision authority. The primary endpoint is unnecessary stroke code activation. Secondary endpoints include allocation accuracy, safety, door-to-needle and door-to-groin times, modified Rankin Scale at 3 months, health-related quality of life, healthcare utilization, stakeholder satisfaction, and cost-effectiveness. Outcome assessors for 3-month follow-up measures are blinded to allocation. Data are collected in Castor EDC, and analyses follow the intention-to-treat principle
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)
盲法说明
The study is open-label for participants, ambulance professionals, and treating neurologists. Outcomes assessors for 3-month mRS and EQ-5D-5L assessments are blinded to treatment allocation
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
- •Age 18 years or older
- •Stroke code activation by ambulance professional during office hours
- •Symptom onset < 24 hours or uncertain onset
- •The patient is deemed capable of understanding the study information and making a decision about participation/opt-out
排除标准
- •- Age under 18 years
研究组 & 干预措施
Telestroke Triage + Standard Care
Ambulance professionals receive real-time neurologist consultation via the SMART Triage platform in addition to standard prehospital stroke care.
干预措施: Telestroke triage (Other)
Standard Care
RAV Hollands Midden triage protocol without telestroke consultation.
干预措施: Standard Care (in control arm) (Other)
研究者
NyikaKruyt
Principal Investigator
Leiden University Medical Center