Predictors of Outcome in t-PA Treated Stroke.
NCT01498042 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 162
Last updated 2023-02-08
Summary
Stroke is among the most disabilitating diseases worldwide in terms of numbers affected and its consequences. A relatively new and well documented treatment of acute ischemic stroke today is tPA (tissue plasminogen activator; will be called thrombolysis from now on) Unfortunately only a minority of patients is given this treatment.
The large randomised controlled trials that investigated the safety and efficacy of thrombolytic therapy in treatment of acute stroke did not include patients over 80 years. In an aging population in the western world it will be of importance to investigate whether this treatment is safe and effective in this group.
Both Sorlandet hospital Kristiansand Norway and Bergen hospital have administered thrombolysis to selected patients over 80 years the last years. In addition there has been a registration of patients in stroke registers at both locations. This lays a foundation for further investigation. In association with Bergen the investigators have included 77 patients over 80 years treated with thrombolysis. In addition the investigators have 85 patients treated with tpa below 80 years. In our cohort the investigators are going to compare outcome in the 2 groups. In addition the investigators are going to perform a regression analysis of selected variables to see if there is an association of those variables with predefined outcome measures. Our outcome measures is as follows: mRS=6 (death)and mRS 0-1(good outcome) on 3 months control. The third outcome measure will be developement of sICH secondary to tPA treatment. As definition of sICH we have chosen the same definition as Ecass.
Conditions
Sponsors & Collaborators
-
Sorlandet Hospital HF
lead OTHER_GOV
Principal Investigators
-
Aase Mygland, MD, PhD · Sørlandet sykehus HF
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-01-31
- Primary Completion
- 2010-02-28
- Completion
- 2010-02-28
Countries
- Norway
Study Locations
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