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Completed

NCT Number: NCT01498042

Predictors of Outcome in t-PA Treated Stroke.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sørlandet sykehus HF

Kristiansand, 4600, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with acute ischemic stroke treated with thrombolysis over 80 years between 01.01.2007-28.02.2010 from predefined centers.
  • Patients with acute ischemic stroke treated with thrombolysis at Sorlandet hospital Kristiansand below 80 years in the same defined period.

Two patients were excluded due to missing data at three months control

Treatment and study plan

Primary outcomes

  1. Intravenous thrombolysis for acute ischemic stroke with 4.5 hours time-window and no upper age limit

    Time frame: 2007-2010 (3 yrs)

    Functional outcome and complications 3 months after thrombolysis in patients over 80 and under 80 years.

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Official study title

Ischemic Stroke Treated With iv Thrombolysis Within 4.5 Hours: Predictors of Outcome in a Cohort With a Large Proportion of Patients Above 80 Years

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 23, 2011
Registry last updated
Feb 8, 2023

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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