Earlier Mobilization Post Acute Thrombolysis

Phase 3

Withdrawn

• Conditions: Stroke, Ischemic; Stroke; Stroke, Acute
• Interventions: Behavioral: Mobilization

• Registration Number: NCT04153942
• Lead Sponsor: Brian Silver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-06
• Study Start: 2023-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-30
• Primary Completion: 2024-07
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12-Hour Bed Rest	Mobilization	Subjects will be mobilized 12 hours after receiving IV thrombolysis therapy per usual care
24-Hour Bed Rest	Mobilization	Subjects will be mobilized 24 hours after receiving IV thrombolysis therapy per usual care

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Readmission	90 days post bed rest	Determine whether rates of readmission are at least similar in the two arms.
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.
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.