Contact information
Type
Scientific
Primary contact
Dr Kris Bowles
ORCID ID
Contact details
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
-
KRISTIAN.BOWLES@nnuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9199
Study information
Scientific title
Investigation of the clinical utility of platelet function testing following stroke and transient ischaemic attack: a non-randomised observational clinical laboratory study
Acronym
PASS
Study hypothesis
Platelet aggregation or stickiness is a fundamental part of having a stroke or transient ischaemic attack (TIA). Most patients following a stroke take anti-platelet drugs (e.g. aspirin) to specifically deal with this aspect of the illness, and aspirin and drugs like it have provided significant clinical benefit in terms of reducing further strokes for this patient group. Despite this anti-platelet drug treatment a number of patients go on to have further strokes (and heart attacks). We and others believe that resistance to the drugs accounts for a significant number of aspirin or anti-platelet drug failure and this may affect between 5-35% of patients. As yet we have no routinely clinically useful way of effectively and reliably assessing the effect of the antiplatelet drugs in stroke patients.
Our principal objective is to investigate the clinical utility of platelet function analysis in predicting outcomes following stroke and transient ischaemic attacks (TIA). We will be using a new generation of platelet function analysers about the size of a home computer which if found to be useful could be used in any hospital or clinic.
The study requires from the patient a blood test (one 4 ml blood tube per test on one or two occasions) where possible at the time of normal blood testing. As this automated technology for platelet function testing is new it first needs to be evaluated in our hands as follows:
1. Determine the normal reference range and imprecision of the multiplate (platelet function analyser) instrument in the NNUH laboratory in 20 healthy volunteers who do not take anti-platelet therapy and compare to published data
2. Determine the imprecision of the multiplate instrument in acute stroke patients who are receiving antiplatelet therapy
3. Establish the optimal time for testing platelet function in acute stroke patients following commencement of aspirin therapy
4. Establish the reproducibility of the multiplate test in normal
Ethics approval
MREC (ref: 09/H0310/92)
Study design
Single-centre non-randomised observational clinical laboratory study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stroke
Intervention
1. The observations consist of a blood test to assess platelet function following stroke/TIA
2. Follow-up length: 12 months
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Platelet function result at time of stroke/TIA
Secondary outcome measures
Measured at at 90 days and 1 year:
1. Re-stroke
2. Other vascular event
3. Death
Overall trial start date
01/02/2010
Overall trial end date
31/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Over the age of 18 years old (we are a department that treats adult patients)
2. Patient admitted under the care of the department of medicine with a stroke/transient ischaemic attack (TIA) at the Norfolk and Norwich Hospital
3. Within 72 hours of admission with a stroke/TIA
4. Must have received one dose of at least 75 mg of aspirin orally before testing
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 80
Participant exclusion criteria
1. Unfit for procedure (phlebotomy)
2. Patients not given aspirin
Recruitment start date
01/02/2010
Recruitment end date
31/03/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Colney Lane
Norwich
NR4 7UY
United Kingdom
Sponsor information
Organisation
Norfolk and Norwich University Hospital NHS Foundation Trust (UK)
Sponsor details
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
British Society for Haematology (BSH) (UK)
Alternative name(s)
BSH
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in https://www.ncbi.nlm.nih.gov/pubmed/24981148