Stroke
Conditions
Brief summary
The purpose of the trial is to study the safety and the effectiveness of using CT Perfusion studies as an indicator to treat stroke patients with unknown time of onset.
Interventions
DRUGAnti-platelets and statin
DRUGalteplase
Full dose Intravenous thrombolysis * 0.9 mg/kg * Maximum dose is 90 mg * 10% of the dose will be given over one minute * 90% of the dose will be infused over 1 hour * Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications * Neuro checks every 5 minutes during the infusion * Neuro checks every hour after the infusion for 24 hours
PROCEDUREintra arterial intervention
1. Intra arterial Activase (Maximum dose of 22 mg) 2. MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes) 3. PENUMBRA device (no standard time frame for how long the procedure takes)
Sponsors
University at Buffalo Neurosurgery
Genentech, Inc.
Jacobs Neurological Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of Emergency Department presentation: 1. Age: 18-80 years old 2. Ischemic Wake Up Stroke (Unknown time of onset but less than 24 hours since last seen normal) 3. National Institute of Health Stroke Scale (NIHSS) 8-22 4. Evidence of penumbra on Computed Tomography Perfusion(CTP) as mentioned above 5. Alberta Stroke Program Early Computed Tomography (CT) Score (ASPECTS 7 or more) 6. Signed informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) | 90 days | Modified Rankin Scale (mRS) 90 days post treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) | 30 post treatment | Modified Rankin Scale (mRS) at 30 days post treatment |
| National Institute of Health Stroke Scale (NIHSS) | 24 hour | National Institute of Health Stroke Scale (NIHSS) 24 hours post treatment. |
| Thrombolysis In Myocardial Infarction (TIMI) Flow | Pre - up to1 hour prior to procedure and post will be up to1 hour after completion of procedure | Thrombolysis In Myocardial Infarction (TIMI) flow pre and post the intervention as an indicator of revascularization rate |
| Thomboylsis in Cerebral Ischemia (TICI) flow | Pre - will be no more than 1 hour prior to procedure and post will be no more then 1 hour after completion of procedure | Thomboylsis in Cerebral Ischemia (TICI) flow pre and post intervention as an indicator of revascularization rate |
| symptomatic intracranial Hemorrhage (ICH) | 72 hours | Incidence of symptomatic symptomatic intracranial Hemorrhage (ICH) within 72 hours of intervention defined by ECASSIII as 4 points worsening in NIHSS |
Countries
United States
Contacts
Primary ContactTareq Kass-Hout, MD
Outcome results
None listed