Earlier Mobilization Post Acute Thrombolysis (EMPATHY-I)

Brian Silver

Status and phase: Withdrawn; Phase 3

Conditions: Stroke; Stroke, Acute; Stroke, Ischemic

Treatments: Behavioral: Mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT04153942

H00018238

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

12-Hour Bed Rest

Experimental group

Description:

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

Treatment:

Behavioral: Mobilization

24-Hour Bed Rest

Active Comparator group

Description:

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

Treatment:

Behavioral: Mobilization