Specialist pre-hospital redirection for ischaemic stroke thrombectomy (SPEEDY)

Plain English Summary

Background and study aims
Stroke is a common medical emergency and time-critical treatments reduce the chance of disability or death. About 1 in 10 patients are suitable for an emergency operation to remove blood clots blocking large arteries in the brain (known as thrombectomy) which greatly improves their chances of recovery. However, this operation is only available at specialist regional hospitals and unless patients live nearby, they are first admitted to their local hospital and must be transferred for treatment. A transfer typically delays thrombectomy by at least 90 minutes and reduces its benefit. Faster treatment might occur if patients could attend specialist regional hospitals directly but at present no accurate assessment or portable test exists to guide ambulance staff to make a confident diagnosis of stroke, or to determine that thrombectomy is needed.
In an earlier research project, a specialist prehospital redirection pathway was developed which involves communication between ambulance practitioners and specialist hospital thrombectomy staff to decide whether the emergency operation is likely to be required, followed by direct admission to the specialist hospital if this is the case. This study will now test the impact of this new pathway.

Who can participate?
All suspected and confirmed acute stroke patients from participating geographical regions will be involved

What does the study involve?
Ambulance stations (work bases for ambulance practitioners) or ambulance staff teams will be assigned at random to use the new pathway or to continue with current standard care when attending suspected stroke patients. Data will be collected about thrombectomy treatments and other aspects of emergency medical care received which will be compared between the two groups.

What are the possible benefits and risks of participating?
This study is testing whether a new emergency care pathway improves access to thrombectomy treatment for some people. The pathway may result in faster treatment and better recovery after stroke but this is not yet known.

Where is the study run from?
Newcastle University (UK)

When is the study starting and how long is it expected to run for?
August 2021 to July 2026

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Lisa Shaw, lisa.shaw@newcastle.ac.uk

Study website

Type

Scientific

Contact name

Dr Lisa Shaw

ORCID ID

Contact details

Stroke Research Group
Population Health Sciences Institute
The Medical School
Newcastle University
Newcastle
NE2 4HH
United Kingdom
+44 (0)191283826
lisa.shaw@newcastle.ac.uk

EudraCT/CTIS number

Nil known

IRAS number

312053

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 53148, IRAS 312053

Scientific title

Specialist pre-hospital redirection for ischaemic stroke thrombectomy (SPEEDY): a cluster randomised controlled trial with included health economic and process evaluations

Acronym

SPEEDY

Study hypothesis

The aim of the study is to determine the clinical and cost-effectiveness of a novel specialist prehospital redirection pathway intended to facilitate thrombectomy treatment for acute stroke.

Ethics approval(s)

Approved 26/06/2022, North East - Newcastle & North Tyneside 1 Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 1048091; newcastlenorthtyneside2.rec@hra.nhs.uk), ref: 22/NE/0103

Study design

Randomized; Interventional; Design type: Process of Care, Complex Intervention, Management of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Other

Study type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Suspected and confirmed acute stroke

Intervention

This research study is a multicentre cluster randomised controlled trial with included health economic and process evaluations. The intervention to be evaluated is a new pathway which involves communication between ambulance and specialist hospital staff to select patients for direct admission to a specialist regional hospital who are likely to need emergency thrombectomy treatment. Clusters will be ambulance stations (work bases for ambulance practitioners) or ambulance staff teams which prior to the start of the study will be assigned at random to use the new pathway or to continue with current standard care when attending suspected stroke patients.

Intervention type

Other

Primary outcome measure

Data collected from routine healthcare sources throughout the study period:
1. Thrombectomy rate
2. The time from stroke symptom onset to thrombectomy (when thrombectomy is received)

Secondary outcome measures

Data collected from routine healthcare sources throughout the study period:
1. Key emergency care time intervals
2. Receipt of and time to thrombolysis treatment
3. Stroke severity 24 hours post reperfusion treatment (NIHSS)
4. Length of hospital stay
5. Dependency at discharge (mRS)

Overall study start date

01/08/2021

Overall study end date

31/07/2026

Reason abandoned (if study stopped)

Participant inclusion criteria

1. An ambulance practitioner from a randomised station/team attended the incident
2. Conveyance was to either a local stroke hospital which refers patients to the participating specialist regional hospital, or directly to the participating specialist regional hospital
3. Acute stroke was suspected by the attending ambulance practitioner (i.e. Face, Arm, Speech Test (FAST) positive or any observed new focal neurological symptoms which indicated acute stroke according to the ambulance practitioner’s clinical judgement) OR acute stroke was diagnosed following arrival at a participating hospital irrespective of ambulance practitioner initial judgement of symptom cause

Participant type(s)

Mixed

Age group

Adult

Sex

Both

Target number of participants

Planned Sample Size: 80000; UK Sample Size: 80000

Participant exclusion criteria

Does not meet the inclusion criteria

Recruitment start date

01/09/2022

Recruitment end date

31/12/2025

Countries of recruitment

England, United Kingdom

Study participating centre

North East Ambulance Service NHS Ft
Bernicia House
Goldcrest Way
Newcastle upon Tyne
NE15 8NY
United Kingdom

Study participating centre

The Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Study participating centre

North West Ambulance Service NHS Trust
Ladybridge Hall
399 Chorley New Road
Bolton
BL1 5DD
United Kingdom

Study participating centre

Lancashire Teaching Hospitals NHS Foundation Trust
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom

Study participating centre

Salford Royal NHS Foundation Trust
Salford Royal
Stott Lane
Salford
Manchester
M6 8HD
United Kingdom

Study participating centre

West Midlands Ambulance Service University NHS Foundation Trust
Millennium Point
Waterfront Business Park
Dudley Road
Brierley Hill
DY5 1LX
United Kingdom

Study participating centre

University Hospitals of North Midlands NHS Trust
Newcastle Road
Stoke-on-trent
ST4 6QG
United Kingdom

Study participating centre

University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom

Study participating centre

South Western Ambulance Service NHS Foundation Trust
Abbey Court
Eagle Way
Exeter
EX2 7HY
United Kingdom

Study participating centre

North Bristol NHS Trust
Southmead Hospital
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

c/o Aaron Jackson
Level 1
Regent Point
Regent Farm Road
Gosforth
Newcastle-Upon-Tyne
NE3 3HD
England
United Kingdom
+44 (0)1912825789
aaron.jackson@nhs.net

Sponsor type

Hospital/treatment centre

Website

http://www.newcastle-hospitals.org.uk/

ROR

https://ror.org/05p40t847

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: NIHR202361

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

Intention to publish date

31/07/2027

Individual participant data (IPD) sharing plan

The data sharing plans for the current study are unknown and will be made available at a later date

IPD sharing plan summary

Data sharing statement to be made available at a later date

Study outputs