Norfolk Platelet And Stroke Study (PASS)
| ISRCTN | ISRCTN09053426 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09053426 |
| Secondary identifying numbers | 9199 |
- Submission date
- 11/02/2011
- Registration date
- 18/07/2011
- Last edited
- 16/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Kris Bowles
Scientific
Scientific
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
| KRISTIAN.BOWLES@nnuh.nhs.uk |
Study information
| Study design | Single-centre non-randomised observational clinical laboratory study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Investigation of the clinical utility of platelet function testing following stroke and transient ischaemic attack: a non-randomised observational clinical laboratory study |
| Study acronym | PASS |
| Study objectives | 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(s) | MREC (ref: 09/H0310/92) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/02/2010 |
| Completion date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 80 |
| Key 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 |
| Key exclusion criteria | 1. Unfit for procedure (phlebotomy) 2. Patients not given aspirin |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 31/03/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Colney Lane
Norwich
NR4 7UY
United Kingdom
NR4 7UY
United Kingdom
Sponsor information
Norfolk and Norwich University Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Colney Lane
Colney
Norwich
NR4 7UY
England
United Kingdom
| Website | http://www.nnuh.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/01wspv808 |
Funders
Funder type
Research organisation
British Society for Haematology (BSH) (UK)
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- BSH
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2015 | Yes | No |
Editorial Notes
16/03/0217: Publication reference added.
