Stroke, Stroke, Acute, Stroke, Ischemic
Conditions
Keywords
Mobilization, Thrombolysis, Ischemia, Cerebrovascular Disorders, Brain Diseases, Recovery
Brief summary
This is a phase III trial trying to determine whether 12-hour bed rest following IV thrombolysis therapy (i.e. tPA) for ischemic stroke is non-inferior to 24-hour bed rest by measure of outcomes on the modified Rankin Scale (mRS) at 90 days post bed rest.
Interventions
BEHAVIORALMobilization
Any movement out of bed
Sponsors
Brian Silver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors blind to the subject's treatment/arm will do the evaluations at 90 days
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Received intravenous tPA for a clinical diagnosis of acute ischemic stroke * Patient and/or Legally Authorized Representative provide consent
Exclusion criteria
* Venous thromboembolism present at symptom onset * Pneumonia present at symptom onset * STEMI at symptom onset * Positive troponins at symptom onset according to local values * Bone fracture at symptom onset * Treatment includes or anticipated to include thrombectomy * Intubation anticipated or occurred * Symptomatic intracranial hemorrhage (defined as increase in NIHSS by 4 points or more accompanied by PH2 hemorrhage on imaging) at the time of screening. * Pre-screening systolic blood pressure \< 110 mmHg * Resting pulse oximetry \< 92% (with or without supplemental oxygen) * Neurological worsening (defined as NIHSS increase of 4 points compared to initial score) prior to screening. * Baseline modified Rankin Scale score \> 2 * Known pregnancy * Patient not anticipated to survive 3 months * Patient not anticipated to follow-up at 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90 day mRS | 90 days post bed rest | Proportion of patients with a modified Rankin Scale score (min 0, max 5 with 0 being best outcome) of 0-2 at 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pneumonia | Duration of hospitalization stay, average 5 days | Determine whether rates of pneumonia are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk. |
| Venous Thromboembolism | Duration of hospitalization stay, average 5 days | Determine whether rates of VTE are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk. |
| Neurological Worsening | Duration of hospitalization stay, average 5 days | Determine whether rates of neurological worsening are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk. |
| Readmission | 90 days post bed rest | Determine whether rates of readmission are at least similar in the two arms. |
| Length of Stay | Duration of hospitalization stay, average 5 days | Determine whether hospital length of stay are at least similar in the two arms. This will ve measured in days. |
Outcome results
None listed