NCT04153942
Withdrawn
Phase 3
Earlier Mobilization Post Acute Thrombolysis
Brian Silver0 sitesAugust 2023
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Brian Silver
- Primary Endpoint
- 90 day mRS
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
Investigators
Brian Silver
Principal Investigator
University of Massachusetts, Worcester
Eligibility Criteria
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)
Outcomes
Primary Outcomes
90 day mRS
Time Frame: 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 Outcomes
- Pneumonia(Duration of hospitalization stay, average 5 days)
- Venous Thromboembolism(Duration of hospitalization stay, average 5 days)
- Neurological Worsening(Duration of hospitalization stay, average 5 days)
- Length of Stay(Duration of hospitalization stay, average 5 days)
- Readmission(90 days post bed rest)
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