Leiden University Medical Center
Leiden, South Holland, 2333 ZA, Netherlands
NCT Number: NCT07657117
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Leiden, South Holland, 2333 ZA, Netherlands
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Live tele-neurologist consultation via the SMART Triage platform during ambulance assessment of suspected stroke.
Usual prehospital stroke triage according to RAV Hollands Midden protocols without telestroke consultation.
Time frame: Immediately after the prehospital triage decision
Proportion of patients allocated to the appropriate level of care, including comprehensive stroke center, primary stroke center, or home discharge when clinically appropriate.
Time frame: Through initial emergency department stroke evaluation
Proportion of ambulance-suspected stroke patients in whom stroke code activation leads to in-hospital stroke team activation and CT scan preparedness, while final work-up shows no stroke or no indication for immediate neuro-intervention.
Contact information is provided by the study sponsor or research team.
Nyika D Kruyt, PhD
CONTACT
Robert Croese, MD
CONTACT
NyikaKruyt
Other
Ambulance Stroke Triage Assisted by Telemedicine (ASTRAL) Trial.
Acronym: ASTRAL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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