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This is a phase III trial trying to determine whether 12-hour bed rest following thrombectomy 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12-Hour Bed Rest | Experimental | Subjects will be mobilized 12 hours after undergoing thrombectomy per usual care |
|
| 24-Hour Bed Rest | Active Comparator | Subjects will be mobilized 24 hours after undergoing thrombectomy per usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobilization | Behavioral | Any movement out of bed |
|
| Measure | Description | Time Frame |
|---|---|---|
| 90 Day Modified Rankin Scale (mRS) score | Proportion of patients with a modified Rankin Scale score (min 0, max 5 with 0 being the best outcome) of 0-2 at 90 days | 90 days post bed rest |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Silver, MD | UMass Medical School | Principal Investigator |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D007511 | Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Assessors blind to the subject's treatment/arm will do the evaluations at 90 days
Determine whether rates of Venous Thromboembolism (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 length of hospital stay are at least similar in the two arms. This will be measured in days. | Duration of hospitalization stay, average 5 days |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |