Condition category
Nervous System Diseases
Date applied
05/11/2015
Date assigned
05/11/2015
Last edited
05/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A stroke is a serious condition where the blood supply to a part of the brain is cut off, usually by a blood clot blocking an artery or a bleed (haemorrhage). The majority of strokes are ischemic strokes. Ischemic strokes happen when the arteries that supply the brain with oxygen (carotid arteries) become narrowed or blocked, causing severely reduced blood flow (ischemia). As we age, a gradual build-up of a sticky substance called plaque can build-up in one or both of the carotid arteries. When there is a lot of plaque, particularly with a rough or irregular surface, blood clots can develop, depriving the brain of oxygen and leading to an acute ischemic stroke (AIS). This can lead to irreversible damage to the brain and long-term disability if not treated quickly. Thrombolysis, also known as “clot busting”, is a drug treatment that breaks down clots, helping to restore the blood supply to the brain. The quicker this treatment is given, the better the patient’s chance of recovery. Unfortunately, many patients do not receive thrombolysis quickly enough, as the decision to give it relies on specialist assessments, which take place after they have been admitted to hospital. Quicker access to important stroke treatments such as thrombolysis is needed, and paramedics may be able to play a more important role. Paramedic acute stroke treatment assessment (PASTA) is a new care pathway in which paramedics perform an enhanced role in stroke assessment. This involves taking down more information about the patient, providing a structured handover of stroke information to medical professionals and assistance with urgent tasks when they arrive at the hospital with the patient. The aim of this study is to find out whether implementing PASTA could have a beneficial effect on patients’ long-term recovery from an acute stroke.

Who can participate?
Adults who have suffered an acute stroke, and have been assessed by a study paramedic within 4 hours.

What does the study involve?
Study participants receive either the PASTA pathway or usual emergency stroke care, according to the paramedic who attends their emergency call. Before the start of the study, paramedics are randomly allocated to provide the PASTA pathway or to continue with usual emergency stroke care. Participants are also asked to undergo a telephone interview or to complete a postal questionnaire at 90 days after stroke. This records details about recovery after stroke, including any help required with day to day activities, and rehabilitation received since discharge from hospital.

What are the possible benefits and risks of participating?
The PASTA pathway may improve recovery, but this is not yet proven. There may be no benefits to individuals who take part in the study, however, it is hoped that care for future stroke patients will be improved as a result of this research. There are no notable risks of participating.

Where is the study run from?
North East England, North West England and Wales (UK)

When is the study starting and how long is it expected to run for?
November 2015 to April 2018

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

Who is the main contact?
Dr Rachel Lakey

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rachel Lakey

ORCID ID

Contact details

Newcastle Clinical Trials Unit
1-4
Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20052

Study information

Scientific title

Paramedic Acute Stroke Treatment Assessment (PASTA)

Acronym

PASTA

Study hypothesis

The aim of this study is to determine the clinical-and cost-effectiveness of an enhanced Paramedic Acute Stroke Treatment Assessment (PASTA) pathway.

Ethics approval

National Research Ethics Service Committee North East - Newcastle & North Tyneside 1, 09/11/2015, ref: 15/NE/0309

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Stroke; Subtopic: Acute Care; Disease: In hospital study, Community study

Intervention

Participants will randomly receive either the Paramedic Acute Stroke Treatment Assessment (PASTA) pathway or usual emergency stroke care, according to the paramedic that attends their emergency call. The PASTA pathway is a care pathway where paramedics perform an enhanced role in stroke assessment including additional pre-hospital information collection, structured handover of stroke information at hospital and assistance with urgent tasks on hospital arrival.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Dependency measured using the modified Rankin Scale (mRS) at 90 days after stroke.

Secondary outcome measures

1. Stroke severity measured by the National Institute of Health Stroke Scale at 24 hours after thrombolysis
2. Medical complications at 24 hours after thrombolysis
3. Dependency (mRS), discharge destination and assistance with activities of daily living required, at discharge from hospital
4. Residence and assistance with activities of daily living required at 90 days after stroke

Overall trial start date

01/01/2015

Overall trial end date

30/04/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Paramedics allocated to delivering the PASTA pathway will be asked to deliver this to the following patients:
1. Aged 18 years and over.
2. Face Arm Speech Test (FAST) positive or any presentation of new focal neurological symptoms which indicate acute stroke in the paramedic's clinical judgement.
3. Within 4 hours of last known to be without new stroke symptoms in the paramedic’s judgement.
4. Admission to a study hospital

Patients will be identified and approached about enrolment in the study after arrival at hospital. Patients approached about enrolment will meet the following criteria:
1. Travelled to hospital with a study paramedic
2. Aged 18 years and over
3. Hospital specialist diagnosis of stroke
4. Within 4 hours of stroke onset (onset time determined by the hospital stroke team) when assessed by the study paramedic

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 3640; UK Sample Size: 3640; Description: The sample sixe is 3640 patients (1820 participants per group)

Participant exclusion criteria

Not meeting the inclusion criteria.

Recruitment start date

01/12/2015

Recruitment end date

30/04/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

1st floor
Regent's Point
Regent Farm Road
Newcastle Upon Tyne
NE3 3HD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study will be presented at national and international conferences and submitted for publication in peer reviewed journals.

Intention to publish date

31/12/2019

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes