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ISRCTN
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ISRCTN09053426
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ClinicalTrials.gov identifier
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Public title
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Norfolk Platelet And Stroke Study (PASS)
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Scientific title
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Investigation of the clinical utility of platelet function testing following stroke and transient ischaemic attack: a non-randomised observational clinical laboratory study
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Acronym
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PASS
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Serial number at source
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9199
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Study hypothesis
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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
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Lay summary
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Not provided at time of registration
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Ethics approval
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MREC (ref: 09/H0310/92)
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Study design
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Single centre non-randomised observational clinical laboratory study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Stroke
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Participants - inclusion criteria
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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 1 dose of at least 75 mg of aspirin orally before testing
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Participants - exclusion criteria
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1. Unfit for procedure (phlebotomy)
2. Patients not given aspirin
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Anticipated start date
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01/02/2010
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Anticipated end date
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31/03/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 80
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Interventions
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1. The observations consist of a blood test to assess platelet function following stroke/TIA
2. Follow-up length: 12 months
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Primary outcome measure(s)
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Platelet function result at time of stroke/TIA
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Secondary outcome measure(s)
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Measured at at 90 days and 1 year:
1. Re-stroke
2. Other vascular event
3. Death
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Sources of funding
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British Society for Haematology (BSH) (UK)
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Trial website
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Publications
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Contact name
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Dr
Kris
Bowles
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Address
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Colney Lane
Colney
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City/town
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Norwich
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Zip/Postcode
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NR4 7UY
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Country
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United Kingdom
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Email
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KRISTIAN.BOWLES@nnuh.nhs.uk
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Sponsor
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Norfolk and Norwich University Hospital NHS Foundation Trust (UK)
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Address
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Colney Lane
Colney
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City/town
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Norwich
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Zip/Postcode
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NR4 7UY
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Country
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United Kingdom
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Sponsor website:
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http://www.nnuh.nhs.uk/
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Date applied
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11/02/2011
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Last edited
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18/07/2011
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Date ISRCTN assigned
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18/07/2011
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