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OpenTrials
Completed

NCT Number: 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).

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

structured therapeutic chain of stroke treatment

Procedure

Primary outcomes

  1. Mortality, dependence, psychoscial outcome

  2. Mortality, dependence and psychosocial outcome

    Time frame: 6 months endpoint

Sponsors and collaborators

Lead sponsor

Kantonsspital Baden

Other

Collaborators

  • 407 Doctors

Registry information

Important dates

Study start
2002
Study completion
2003
First posted
Oct 16, 2007
Registry last updated
Oct 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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