Promoting acute thrombolysis for ischemic stroke

ISRCTN	ISRCTN20405426
DOI	https://doi.org/10.1186/ISRCTN20405426
Secondary identifying numbers	945-14-217

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Diederik W.J. Dippel
Scientific

PO Box 1738
Rotterdam
3000 DR
Netherlands

Phone	+31 (0)10 4087979
Email	d.dippel@erasmusmc.nl

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	PRACTISE
Study objectives	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
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Stroke
Intervention	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
Intervention type	Other
Primary outcome measure	Treatment with thrombolysis or not in all registered patients
Secondary outcome measures	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).
Overall study start date	01/08/2005
Completion date	01/08/2007

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	7,000
Key inclusion criteria	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
Key exclusion criteria	Age under 18
Date of first enrolment	01/08/2005
Date of final enrolment	01/08/2007

PO Box 1738

Rotterdam
3000 DR
Netherlands

Netherlands Organisation for Health Research and Development (ZonMw)
Research organisation

Laan van Nieuw Oost Indië 334
P.O. Box 93245
The Hague
2509 AE
Netherlands

Research organisation

Netherlands Organisation for Health Research and Development (ZonMw) (945-14-217)
Private sector organisation / Other non-profit organizations

Alternative name(s): Netherlands Organisation for Health Research and Development
Location: Netherlands

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/05/2007		Yes	No
Results article	results	01/09/2013		Yes	No