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
  Purpose

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.


Condition
Ischemic Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • 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.


Enrollment: 162
Study Start Date: January 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
stroke, thrombolysis, over 80, outcome
To study the outcome of stroke patients over 80 years treated with thrombolysis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498042

Locations
Norway
Sørlandet sykehus HF
Kristiansand, Norway, 4600
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Study Chair: Aase Mygland, MD, PhD Sørlandet sykehus HF
  More Information

No publications provided

Responsible Party: Sissel Ledang, Administrator of research, Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT01498042     History of Changes
Other Study ID Numbers: 813387
Study First Received: July 6, 2011
Last Updated: December 20, 2011
Health Authority: Norway: Regional Ethics Commitee
Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 16, 2014