Earlier Mobilization Post Acute Thrombolysis

NCT ID: NCT04153942

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-12-31

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.

Conditions

Stroke; Stroke, Acute; Stroke, Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

12-Hour Bed Rest

Subjects will be mobilized 12 hours after receiving IV thrombolysis therapy per usual care

Group Type: EXPERIMENTAL

Mobilization

Intervention Type: BEHAVIORAL

Any movement out of bed

24-Hour Bed Rest

Subjects will be mobilized 24 hours after receiving IV thrombolysis therapy per usual care

Group Type: ACTIVE_COMPARATOR

Mobilization

Intervention Type: BEHAVIORAL

Any movement out of bed

Interventions

Mobilization

Any movement out of bed

Intervention Type: BEHAVIORAL

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)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brian Silver

OTHER

Sponsor Role: lead

Responsible Party

Brian Silver

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Brian Silver, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Medical School

Other Identifiers

H00018238

Identifier Type: -

Identifier Source: org_study_id