Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06477016

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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