Telestroke Triage in Suspected Stroke Patients (ASTRAL)
17. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
484
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Nyika D Kruyt, PhD
- Telefonnummer: +31 71 526 91 11
- E-mail: n.d.kruyt@lumc.nl
Undersøgelse Kontakt Backup
- Navn: Robert Croese, MD
- E-mail: r.j.i.croese@lumc.nl
Studiesteder
-
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South Holland
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Leiden, South Holland, Holland, 2333 ZA
- Leiden University Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Telestroke Triage + Standard Care
Ambulance professionals receive real-time neurologist consultation via the SMART Triage platform in addition to standard prehospital stroke care.
|
Live tele-neurologist consultation via the SMART Triage platform during ambulance assessment of suspected stroke.
|
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Aktiv komparator: Standard Care
RAV Hollands Midden triage protocol without telestroke consultation.
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Usual prehospital stroke triage according to RAV Hollands Midden protocols without telestroke consultation.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Appropriate Patient Allocation
Tidsramme: 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
|
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Unnecessary Stroke Code Activation
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- Nederlandse Vereniging voor Neurologie (NVN). Richtlijn Stroke 2021: Acute fase. Utrecht: NVN; 2021.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. december 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
5. juni 2026
Først indsendt, der opfyldte QC-kriterier
17. juni 2026
Først opslået (Faktiske)
18. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- N26.022
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
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-delingsadgangskriterier
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-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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