Telestroke Triage in Suspected Stroke Patients (ASTRAL)

June 17, 2026 updated by: NyikaKruyt

Ambulance Stroke Triage Assisted by Telemedicine (ASTRAL) Trial.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

484

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • South Holland
      • Leiden, South Holland, Netherlands, 2333 ZA
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age 18 years or older.

Stroke code activation by ambulance professional during office hours.

Symptom onset less than 24 hours or uncertain onset.

The patient is deemed decisionally capable to understand the study information and make a choice regarding participation/opt-out.

Exclusion Criteria:

Age under 18 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telestroke Triage + Standard Care
Ambulance professionals receive real-time neurologist consultation via the SMART Triage platform in addition to standard prehospital stroke care.
Other: Telestroke triage
Live tele-neurologist consultation via the SMART Triage platform during ambulance assessment of suspected stroke.
Active Comparator: Standard Care
RAV Hollands Midden triage protocol without telestroke consultation.
Other: Standard Care (in control arm)
Usual prehospital stroke triage according to RAV Hollands Midden protocols without telestroke consultation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after the prehospital triage decision
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.
Through initial emergency department stroke evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NyikaKruyt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 5, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N26.022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) will be shared. The shared dataset will include variables needed to reproduce the primary and secondary analyses, such as baseline characteristics, treatment allocation, primary and secondary outcome variables, and key analysis covariates. Direct identifiers will not be shared. Data will be coded and pseudonymized.

IPD Sharing Time Frame

IPD and supporting information will be available after publication of the primary results, beginning 6 months after publication and remaining available for 5 years.

IPD Sharing Access Criteria

Access will be granted to qualified researchers who submit a scientifically sound proposal. Requests will be reviewed by the study team or data access committee, if applicable. Access requires a data use agreement and, where applicable, institutional ethics approval. Only de-identified data necessary for the approved analysis will be shared.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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