Status:
WITHDRAWN
OsciPulse D-dimer Efficacy Trial
Lead Sponsor:
OsciFlex LLC
Collaborating Sponsors:
University of Pennsylvania
Conditions:
Venous Thromboses
Ischemic Stroke
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety and efficacy of the OsciPulse System in reducing serum d-dimer levels in hospitalized ischemic stroke patients.
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Eligible and enrolled patients who have been admitted to the ho...
Eligibility Criteria
Inclusion
- Adult aged ≥ 18 years old
- Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke
- Last known normal \< 24 hours.
- NIH stroke score ≥5
- Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores, items 6A and 6B)
- Prescribed mechanical therapy for DVT prophylaxis.
Exclusion
- Inability or contraindication to applying IPC to both legs such as:
- Evidence of bone fracture in lower extremities
- Burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis,
- ischemic limb in the legs at the site of IPC placement
- Acute ischemia in the lower extremities
- Severe peripheral vascular disease
- Amputated foot or leg on one or two sides
- Compartment syndrome
- Severe lower extremity edema
- Acute deep vein thrombosis
- Subjects who received tPA therapy for their stroke
- Pregnancy or within 6 weeks of postpartum period
- Limitation of life support, life expectancy \< 7 days, or in hospice care
- A head-unit is unavailable for the first 24 hours or more
- At the discretion of the attending physician and / or clinical team, the subject's participation in the study is believed not to be in the best interest of the subject.
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05389488
Start Date
December 1 2022
End Date
March 1 2023
Last Update
November 7 2023
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19146