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NCT Number: NCT07657117

Telestroke Triage in Suspected Stroke Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telestroke triage

Other

Live tele-neurologist consultation via the SMART Triage platform during ambulance assessment of suspected stroke.

Standard Care (in control arm)

Other

Usual prehospital stroke triage according to RAV Hollands Midden protocols without telestroke consultation.

Primary outcomes

  1. Appropriate Patient Allocation

    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.

  2. Unnecessary Stroke Code Activation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nyika D Kruyt, PhD

CONTACT

[email protected]

+31 71 526 91 11

Robert Croese, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

NyikaKruyt

Other

Registry information

Official study title

Ambulance Stroke Triage Assisted by Telemedicine (ASTRAL) Trial.

Acronym: ASTRAL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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