Clinical Trials Directory

Trials / Completed

CompletedNCT01498042

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

Status
Completed
Phase
Study type
Observational
Enrollment
162 (actual)
Sponsor
Sorlandet Hospital HF · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2007-01-01
Primary completion
2010-02-01
Completion
2010-02-01
First posted
2011-12-23
Last updated
2023-02-08

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT01498042. Inclusion in this directory is not an endorsement.