Improved Stroke Outcome at 6 Months

Stroke Clinical Trial

Official title:

Improved Stroke Outcome at 6 Months Attained by a Chain of Structured Acute Treatment With Integrated Rehabilitation and Supported Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122798
• Other study ID #: EK 50
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2005
• Last updated: June 23, 2006
• Start date: January 2002
• Est. completion date: January 2005

Study information

• Verified date: December 2004
• Source: Kantonsspital Baden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial Summary

The investigators implemented a structured chain of acute stroke care with early integrated rehabilitation. The mortality at 6 months was lower (12%) compared to 23% in the International Stroke Trial (IST) and 39% (67%) of the patients were dead or dependent, which is superior compared to international data.

Description:

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) and recent international data.

Results: At 6 months, mortality is significantly lower with 12 % (compared to 23 % in the IST trial) and only 39 % (67 %) of the patients are dead or dependent. Stroke severity is similar as in other study populations. Median LOS is 15 days in the acute clinic and 39 days in the rehabilitation institution. The psychosocial outcome compares favorably to a matched control group.

Conclusions: A structured chain of acute stroke treatment overlapping with an early integrated rehabilitation is superior compared to national and international ischemic stroke trial data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 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 stroke 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 next of kindred

• Living at home before the event

• Lack of participation in another trial

Exclusion Criteria:

• Transient ischemic attack (TIA) resp. full recovery within 24 hours after the event

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Stroke treatment

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baden	Baden	Aargau

Sponsors (2)

Lead Sponsor	Collaborator
Kantonsspital Baden	RehaClinic Zurzach

Country where clinical trial is conducted

Switzerland, 

External Links

•   Link