Condition category
Circulatory System
Date applied
11/02/2011
Date assigned
18/07/2011
Last edited
05/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.nnuh.nhs.uk/

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

professional associations and societies

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes