Predictors of Outcome in t-PA Treated Stroke.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sissel Ledang, Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT01498042
First received: July 6, 2011
Last updated: December 20, 2011
Last verified: December 2011

July 6, 2011
December 20, 2011
January 2007
February 2010   (final data collection date for primary outcome measure)
Intravenous thrombolysis for acute ischemic stroke with 4.5 hours time-window and no upper age limit [ Time Frame: 2007-2010 (3 yrs) ] [ Designated as safety issue: No ]
Functional outcome and complications 3 months after thrombolysis in patients over 80 and under 80 years.
Same as current
Complete list of historical versions of study NCT01498042 on ClinicalTrials.gov Archive Site
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Predictors of Outcome in t-PA Treated Stroke.
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

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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Sorlandet hospital is a secondary hospital. The patients will be drawn from thrombolysis treated patients in its catchement area. A registry of these patients has been ongoing since before the inclusiondate. All thrombolysed patients at Sorlandet will be included in the predefined inclusionperiode. In addition we have enrolled 39 patients treated with thrombolysis from Haukeland hospital; Bergen. These 77 patients over 80 years will be compared to 85 patients below 80 years treated at SSK in the same defined periode.

Ischemic Stroke
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stroke, thrombolysis, over 80, outcome
To study the outcome of stroke patients over 80 years treated with thrombolysis.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
February 2010
February 2010   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01498042
813387
No
Sissel Ledang, Sorlandet Hospital HF
Sorlandet Hospital HF
Not Provided
Study Chair: Aase Mygland, MD, PhD Sørlandet sykehus HF
Sorlandet Hospital HF
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP