A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult aged ≥ 18 years old
• Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke
• \< 24 hours from last known normal or treating-hospital admission.
• NIH stroke score ≥5
• Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores)
• Prescribed mechanical therapy for DVT prophylaxis.
Locations
United States
Pennsylvania
HUP Neurology Dept. of Stroke and Neurocritical Care- University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Steven Messe, MD
Steven.Messe@pennmedicine.upenn.edu
215-662-3363
Backup
Sophia Bautista
Sophia.Bautista@Pennmedicine.upenn.edu
215-662-3487
Time Frame
Start Date: 2025-02-12
Estimated Completion Date: 2027-02
Participants
Target number of participants: 40
Treatments
Experimental: Group A-OsciPulse System
Patients admitted to the neuro intensive care unit or intermediate neurological care unit with a diagnosis of ischemic stroke randomly assigned to Group A.
Active_comparator: Group B- Standard Reference Therapy
Patients admitted to the neuro intensive care unit or intermediate neurological care unit with a diagnosis of ischemic stroke randomly assigned to Group B.
Related Therapeutic Areas
Sponsors
Collaborators: OsciFlex LLC
Leads: University of Pennsylvania