Telestroke Triage in Suspected Stroke Patients

NCT07657117 | Not Yet Recruiting

• 1 other identifier: N26.022
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke triage; prehospital stroke; telestroke; ambulance; stroke code activation

Outcome Measures

Primary Outcomes (2)

• Appropriate Patient Allocation

  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

  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

Study Arms (2)

Telestroke Triage + Standard Care

EXPERIMENTAL

Ambulance professionals receive real-time neurologist consultation via the SMART Triage platform in addition to standard prehospital stroke care.

Other: Telestroke triage

Standard Care

ACTIVE COMPARATOR

RAV Hollands Midden triage protocol without telestroke consultation.

Other: Standard Care (in control arm)

Interventions

Telestroke triage OTHER

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

Telestroke Triage + Standard Care

Standard Care (in control arm) OTHER

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

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Age under 18 years

Sponsors & Collaborators

• NyikaKruyt: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (4)

• Duvekot MHC, Venema E, Rozeman AD, Moudrous W, Vermeij FH, Biekart M, Lingsma HF, Maasland L, Wijnhoud AD, Mulder LJMM, Alblas KCL, van Eijkelenburg RPJ, Buijck BI, Bakker J, Plaisier AS, Hensen JH, Lycklama A Nijeholt GJ, van Doormaal PJ, van Es ACGM, van der Lugt A, Kerkhoff H, Dippel DWJ, Roozenbeek B; PRESTO investigators. Comparison of eight prehospital stroke scales to detect intracranial large-vessel occlusion in suspected stroke (PRESTO): a prospective observational study. Lancet Neurol. 2021 Mar;20(3):213-221. doi: 10.1016/S1474-4422(20)30439-7. Epub 2021 Jan 7.

  PMID: 33422191 BACKGROUND

• Brauckmann V, Hudasch D, Graff P, Riecke T, Aktas G, Mayor J, Macke C. Prehospital neurological emergencies- a survey on the state of prehospital neurological assessment by emergency medical professionals. BMC Emerg Med. 2024 Sep 11;24(1):164. doi: 10.1186/s12873-024-01076-w.

  PMID: 39256650 BACKGROUND

• Nederlandse Vereniging voor Neurologie (NVN). Richtlijn Stroke 2021: Acute fase. Utrecht: NVN; 2021.

  BACKGROUND

• Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.

  PMID: 31662037 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Nyika D Kruyt, PhD

CONTACT

+31 71 526 91 11; n.d.kruyt@lumc.nl

Robert Croese, MD

CONTACT

r.j.i.croese@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized 1:1 to telestroke triage plus standard care or standard care alone in a parallel-group design

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 18, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

NL (1)