Actively Recruiting
OsciPulse D-dimer Pilot Trial
Led by University of Pennsylvania · Updated on 2026-03-30
40
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
O
OsciFlex LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
OsciPulse D-dimer Pilot Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult aged 63 18 years old
- Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke
- Less than 24 hours from last known normal or hospital admission
- NIH stroke score 635
- Weakness in at least one leg (at least 1 point on NIHSS lower extremity motor scores)
- Prescribed mechanical therapy for DVT prophylaxis
You will not qualify if you...
- Unable or not allowed to apply intermittent pneumatic compression (IPC) to both legs due to conditions such as acute bone fracture, burns, lacerations, ulcers, active skin infection, dermatitis at IPC site
- Acute ischemia or severe peripheral vascular disease in lower legs shown by cyanosis, coolness, or lack of pulse
- Amputation of one or both feet or legs
- Compartment syndrome causing swelling and ischemic injury
- Severe lower leg swelling (+4 edema)
- Acute deep vein thrombosis
- Received thrombolytic therapy for stroke
- Known pregnancy or within 6 weeks postpartum
- Life support limitations, life expectancy under 7 days, or hospice care
- No head-unit available within 24 hours of enrollment
- Attending physician or clinical team believes participation is not in patients best interest
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
HUP Neurology Dept. of Stroke and Neurocritical Care- University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
S
Steven Messe, MD
CONTACT
S
Sophia Bautista
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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