Structured Stroke Management Improves Outcome at 6 Months

Stroke Clinical Trial

Official title:

Structured Stroke Management Improves Outcome at 6 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00544622
• Other study ID #: INR50
• Status: Completed
• Phase: N/A
• First received: October 12, 2007
• Last updated: October 16, 2008
• Start date: January 2002
• Est. completion date: March 2003

Study information

• Verified date: October 2008
• Source: Kantonsspital Baden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2003
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• structured therapeutic chain of stroke treatment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kantonsspital Baden	407 Doctors

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality, dependence, psychoscial outcome
Primary	Mortality, dependence and psychosocial outcome		6 months endpoint