Pilot, randomized, non-blinded clinical trial to generate preliminary data to evaluate the impact of the OsciPulse system on serum d-dimer levels compared to standard of care intermittent compression therapy for DVT prophylaxis in patients admitted in the neuro ICU or intermediate neurological care unit with acute ischemic stroke.
This is a single site, randomized open label two arm study. The patient population will be randomly divided into two arms, with one receiving the OsciPulse System and the other receiving standard intermittent compression therapy. Both arms will have the therapy applied within 24 hours of admission and continue during their hospital stay until day 7 or discharge, whichever is shorter, unless clinically required to be removed. Daily d-dimer levels will be assessed until day 7 or discharge. If required beyond day 7, standard compression therapy will be provided. An interim analysis will be performed after 20 subjects are enrolled to evaluate the speed of enrollment and data variability and quality. If indicated, enrollment will be increased up to 40.
Study Type
OBSERVATIONAL
Enrollment
40
Non-invasive device that provides rapid pulses of compression of the calves to modify venous blood flow patterns in immobilized persons.
Non-invasive device that provides rapid pulses of compression of the calves to modify venous blood flow patterns in immobilized persons.
HUP Neurology Dept. of Stroke and Neurocritical Care- University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGChange in serum d-dimer levels.
Relative change in serum d-dimer levels for each subject from baseline to Day 7 or discharge
Time frame: 7 days
Tolerability of the OsciPulse device in the stroke population
Tolerability defined as the number of patients who stop using the device prior to clinical recommendation and by quantitative scoring of subject experience questionnaires.
Time frame: 7 days
Safety of the OsciPulse device in the stroke population
Comparison of the rate of Adverse Events (AE) between the two groups.
Time frame: 7 days
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