OsciPulse D-dimer Pilot Trial
A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer
University of Pennsylvania
40 participants
Feb 12, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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.
Exclusion Criteria8
- \. 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, ulcers, active skin infection or dermatitis, in the lower extremities at the site of IPC placement
- Acute ischemia or severe peripheral vascular disease in the lower extremities as evidenced by cyanotic, cool, pulselessness.
- Amputated foot or leg on one or two sides
- Compartment syndrome (acute injury causing swelling and ischemic injury)
- Severe lower extremity edema (+4 edema as documented by clinical team)
- Acute deep vein thrombosis 2. Subjects who received thrombolytic therapy for their stroke 3. Known pregnancy or within 6 weeks of postpartum period. 4. Limitation of life support, life expectancy \< 7 days, or in hospice care 5. A head-unit is unavailable within 24 hours of study enrollment. 6. 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.
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Interventions
Non-invasive device that provides rapid pulses of compression of the calves to modify venous blood flow patterns in immobilized persons.
Non-invasive device that provides rapid pulses of compression of the calves to modify venous blood flow patterns in immobilized persons.
Locations(1)
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NCT06477016