Earlier Mobilization Post Acute Thrombolysis

Study Overview
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Brief Summary
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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.

Official Title
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Earlier Mobilization Post Acute Thrombolysis

Conditions
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Stroke, Stroke, Acute, Stroke, Ischemic

Intervention / Treatment
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* Behavioral: Mobilization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12-Hour Bed Rest<br>Subjects will be mobilized 12 hours after receiving IV thrombolysis therapy per usual care | Behavioral: Mobilization<br>* Any movement out of bed<br>|
| Active Comparator: 24-Hour Bed Rest<br>Subjects will be mobilized 24 hours after receiving IV thrombolysis therapy per usual care | Behavioral: Mobilization<br>* Any movement out of bed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90 day mRS | Proportion of patients with a modified Rankin Scale score (min 0, max 5 with 0 being best outcome) of 0-2 at 90 days | 90 days post bed rest | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumonia | 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. | Duration of hospitalization stay, average 5 days | 
| Venous Thromboembolism | 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. | Duration of hospitalization stay, average 5 days | 
| Neurological Worsening | 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. | Duration of hospitalization stay, average 5 days | 
| Readmission | Determine whether rates of readmission are at least similar in the two arms. | 90 days post bed rest | 
| Length of Stay | Determine whether hospital length of stay are at least similar in the two arms. This will ve measured in days. | Duration of hospitalization stay, average 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobilization, Thrombolysis, Ischemia, Cerebrovascular Disorders, Brain Diseases, Recovery