NCT06477016Active, not recruiting
OsciPulse D-dimer Pilot Trial
A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 20 Jun 2024
- Start date
- 12 Feb 2025
- Primary completion date
- Feb 2027
- Lead sponsor
- University of Pennsylvania
- Diseases
- Stroke
- NCT number
- NCT06477016
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 12 Feb 2025 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- Compartment syndrome (acute injury causing swelling and ischemic injury)
Other
- 1\. Inability or contraindication to applying IPC to both legs such as:
- Evidence of acute bone fracture in lower extremities
- Amputated foot or leg on one or two sides
- Severe lower extremity edema (+4 edema as documented by clinical team)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HUP Neurology Dept. of Stroke and Neurocritical Care- University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.