- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00544622
Structured Stroke Management Improves Outcome at 6 Months
Background/Aim of the study: To further reduce the 6 months stroke morbidity and mortality in a high volume stroke hospital and to compare the results with national and international data.
Methods: 204 consecutive stroke patients are analyzed in a prospective study in a single center teaching institution. The intervention consists of a structured therapeutic chain of 290 collaborating GPs, a standardised acute hospital proceeding overlapping with an early integrated neurovascular rehabilitation within the same institution. Primary endpoints include death and dependence at 6 months, secondary endpoints are the length of hospital stay (LOS) and the quantitative analysis of physical and psychosocial impairments. The data are directly compared with the same endpoints of the Swiss subgroup of the international stroke trial (IST).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- An acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding (ICB)) with the signs and symptoms of an acute stroke according to the World Health Organisation definition of acute stroke14 within the last 12 hours without the need or possibility of a neurosurgical intervention
- No thrombolytic therapy within the first 3 hours (in order to allow the correct comparison with the Swiss cohort of the IST trial
- The informed consent of the patient or, if not possible, of the relatives
- Living at home before the event
- Lack of participation in another trial.
Exclusion Criteria:
- Thrombolytic therapy within the first 3 hours (in order to allow the correct comparison with the Swiss cohort of the IST trial
- No informed consent of the patient or, if not possible, of the relatives
- Not living at home before the event
- Participation in another trial (26 patients were excluded because of TIA with full recovery within 24 hours after the event)
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mortality, dependence, psychoscial outcome
|
|
|
Mortality, dependence and psychosocial outcome
Time Frame: 6 months endpoint
|
6 months endpoint
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Juerg H. Beer, MD, Department of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INR50
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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