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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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Modified Rankin study
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Central Adjudication of modified Rankin Scale Assessments in Acute Stroke Trials
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Topic
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Stroke
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Portfolio Eligibility
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UKCRN adopted, non-commercial study
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ISRCTN
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EudraCT
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MREC N° |
08/MRE00/72
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UKCRN ID |
5651
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WHO ID
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Research Summary
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A prospective observational study following acute stroke.
We aim to establish whether central adjudication of locally recorded mRs assessments can be performed in a multi-centre trial setting, to clarify the extent of endpoint misclassification and to assess whether this can be addressed with demonstrable improvements in trial statistical power. We will also explore whether a subjective ranking technique can be applied to mRs outcomes and thus provide a more sensitive measure of post-stroke disability.
Patients with a diagnosis of stroke (ischaemic or haemorrhagic) presenting within 48 hours who have a demonstrable deficit on the NIHSS will be studied. Exclusion criteria will include a pre-morbid modified Rankin score of greater than or equal to 3. Follow up will occur at 30 and 90 days, when an mRs assessment will be performed and recorded. All observers will be trained and certified in the use of the mRs and the video equipment. We will also perform video NIHSS assessments at 90 days.
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Study Type |
Observational
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Design Type |
Validation of outcome measures
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Disease(s) |
In hospital study
Community study
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Phase |
N/A
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Current Status
| Open |
| Closure Date | 31/08/2010 |
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Sample Size
| 300 |
| Accrual to Date |
 | 118% |
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Geographical Scope
| UK Multi-Centre |
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Lead Country
| Scotland |
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Open to new sites
| No |
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Main Inclusion Criteria
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Diagnosis of acute stroke (ischaemic or haemorrhagic)
Onset within 48 hours of ictus
Demonstrable deficit on the National Institute of Health Stroke Scale (NIHSS)
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Main Exclusion Criteria
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Pre-morbid modified Rankin score of greater than or equal to 3.
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Chief Investigator(s)
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| Prof Kennedy Lees |
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Further details, please contact
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Dr Jesse Dawson
Glasgow Cardiovascular Research centre
Cardiovascular Research Centre
126 University Place
Glasgow
Lanarkshire
G12 8TA
UNITED KINGDOM
Tel: 0141 211 6395
j.dawson@clinmed.gla.ac.uk
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Funder(s) |
Chief Scientist Office, Department of Health, Scottish Executive
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Sponsor(s) |
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