Predictors of Outcome in t-PA Treated Stroke.

NCT ID: NCT01498042

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 162 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2010-02-28

Brief 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

Ischemic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

stroke, thrombolysis, over 80, outcome

To study the outcome of stroke patients over 80 years treated with thrombolysis.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aase Mygland, MD, PhD

Role: STUDY_CHAIR

Sørlandet sykehus HF

Locations

Sørlandet sykehus HF

Kristiansand, , Norway

Countries

Norway

Other Identifiers

813387

Identifier Type: -

Identifier Source: org_study_id