Condition category
Circulatory System
Date applied
24/06/2005
Date assigned
30/09/2005
Last edited
20/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.practise-trial.org

Contact information

Type

Scientific

Primary contact

Dr Diederik W.J. Dippel

ORCID ID

Contact details

PO Box 1738
Rotterdam
3000 DR
Netherlands
+31 (0)10 4087979
d.dippel@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

945-14-217

Study information

Scientific title

Acronym

PRACTISE

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/08/2005

Overall trial end date

01/08/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

7,000

Participant exclusion criteria

Age under 18

Recruitment start date

01/08/2005

Recruitment end date

01/08/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

PO Box 1738
Rotterdam
3000 DR
Netherlands

Sponsor information

Organisation

Netherlands Organisation for Health Research and Development (ZonMw)

Sponsor details

Laan van Nieuw Oost Indië 334
P.O. Box 93245
The Hague
2509 AE
Netherlands
+31 (0)70 349 5111
info@zonmw.nl

Sponsor type

Research organisation

Website

http://www.zonmw.nl

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) (945-14-217)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

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

2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18705977
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23887843

Publication citations

  1. Protocol

    Dirks M, Niessen LW, Huijsman R, van Wijngaarden J, Minkman MM, Franke CL, van Oostenbrugge RJ, Koudstaal PJ, Dippel DW, , Promoting Acute Thrombolysis for Ischaemic Stroke (PRACTISE)., Int J Stroke, 2007, 2, 2, 151-159, doi: 10.1111/j.1747-4949.2007.00119.x.

  2. Results

    de Ridder I, Dirks M, Niessen L, Dippel D, , Unequal access to treatment with intravenous alteplase for women with acute ischemic stroke., Stroke, 2013, 44, 9, 2610-2612, doi: 10.1161/STROKEAHA.113.002263.

Additional files

Editorial Notes