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ISRCTN
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ISRCTN20405426
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ClinicalTrials.gov identifier
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Public title
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Promoting acute thrombolysis for ischemic stroke
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Scientific title
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Acronym
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PRACTISE
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Serial number at source
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945-14-217
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Study hypothesis
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1. To evaluate the effect of a high intensity implementation strategy compared to a regular intensity strategy
2. Identify success factors and obstacles for implementation of thrombolysis
3. To assess the cost-effectiveness of thrombolysis in routine daily Dutch neurological care settings, taking into account the costs of implementation
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Stroke
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Participants - inclusion criteria
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All patients who are admitted with acute stroke i.e. patients with an acute focal neurological deficit, which cannot be explained by a condition other than stroke, and onset of symptoms not longer than 24 hours ago
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Participants - exclusion criteria
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Age under 18
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Anticipated start date
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01/08/2005
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Anticipated end date
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01/08/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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7,000
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Interventions
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The high intensity intervention consists of the introduction of a set of implementation tools, directed at the four levels where barriers are expected. This toolkit will be explained in a training session to the vascular neurologist and coordinating nurse in each center, who also act as the local agents of change. Training session takes place after 6 months and 1 year.
Control: regular intensity strategy
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Primary outcome measure(s)
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Treatment with thrombolysis or not in all registered patients
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Secondary outcome measure(s)
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Admission within 3 hours after onset of symptoms, death or disability at three months (in the subgroup of patients with ischemic stroke who were admitted within 3 hours).
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Sources of funding
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Netherlands Organisation for Health Research and Development (ZonMw) (945-14-217)
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Trial website
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http://www.practise-trial.org
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Publications
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2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18705977
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Contact name
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Dr
Diederik W.J.
Dippel
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Address
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PO Box 1738
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City/town
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Rotterdam
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Zip/Postcode
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3000 DR
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Country
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Netherlands
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Tel
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+31 (0)10 4087979
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Fax
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+31 (0)10 4089446
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Email
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d.dippel@erasmusmc.nl
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Sponsor
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Netherlands Organisation for Health Research and Development (ZonMw)
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Address
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Laan van Nieuw Oost Indië 334
P.O. Box 93245
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City/town
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The Hague
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Zip/Postcode
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2509 AE
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Country
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Netherlands
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Tel
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+31 (0)70 349 5111
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Fax
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+31 (0)70 349 5100
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Email
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info@zonmw.nl
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Sponsor website:
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http://www.zonmw.nl
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Date applied
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24/06/2005
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Last edited
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11/09/2009
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Date ISRCTN assigned
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30/09/2005
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