A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer
University of Pennsylvania
Summary
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.
Description
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 perfo…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult aged ≥ 18 years old 2. Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke 3. \< 24 hours from last known normal or treating-hospital admission. 4. NIH stroke score ≥5 5. Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores) 6. Prescribed mechanical therapy for DVT prophylaxis. Exclusion Criteria: 1\. Inability or contraindication to applying IPC to both legs such as: * Evidence of acute bone fracture in lower extremities * Acute burns in the lower extremities, lacerations, u…
Interventions
- DeviceOsciPulse
Non-invasive device that provides rapid pulses of compression of the calves to modify venous blood flow patterns in immobilized persons.
- DeviceIntermittent Pneumatic Compression
Non-invasive device that provides rapid pulses of compression of the calves to modify venous blood flow patterns in immobilized persons.
Location
- HUP Neurology Dept. of Stroke and Neurocritical Care- University of PennsylvaniaPhiladelphia, Pennsylvania