Promoting acute thrombolysis for ischemic stroke
| ISRCTN | ISRCTN20405426 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20405426 |
| Protocol serial number | 945-14-217 |
| Sponsor | Netherlands Organisation for Health Research and Development (ZonMw) |
| Funder | Netherlands Organisation for Health Research and Development (ZonMw) (945-14-217) |
- Submission date
- 24/06/2005
- Registration date
- 30/09/2005
- Last edited
- 20/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Diederik W.J. Dippel
Scientific
Scientific
PO Box 1738
Rotterdam
3000 DR
Netherlands
| Phone | +31 (0)10 4087979 |
|---|---|
| d.dippel@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Treatment with thrombolysis or not in all registered patients |
| Key secondary outcome measure(s) |
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). |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 7000 |
| 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
PO Box 1738
Rotterdam
3000 DR
Netherlands
3000 DR
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2013 | Yes | No | |
| Protocol article | protocol | 01/05/2007 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |