Stroke
Conditions
Keywords
stroke triage, prehospital stroke, telestroke, ambulance, stroke code activation
Brief summary
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.
Detailed description
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
Interventions
OTHERTelestroke triage
Live tele-neurologist consultation via the SMART Triage platform during ambulance assessment of suspected stroke.
OTHERStandard Care (in control arm)
Usual prehospital stroke triage according to RAV Hollands Midden protocols without telestroke consultation.
Sponsors
NyikaKruyt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
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
Intervention model description
Participants will be randomized 1:1 to telestroke triage plus standard care or standard care alone in a parallel-group design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
\- Age under 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Appropriate Patient Allocation | 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. |
| Unnecessary Stroke Code Activation | 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. |
Countries
Netherlands
Contacts
CONTACTNyika D Kruyt, PhD
CONTACTRobert Croese, MD
Outcome results
None listed