Evaluating the OsciPulse system for DVT prevention in stroke patients
A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer
This study is testing if the OsciPulse system can lower blood clot risk in stroke patients better than standard compression therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06477016 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to assess the effectiveness of the OsciPulse system in reducing serum d-dimer levels compared to standard intermittent compression therapy in patients with acute ischemic stroke. Participants will be randomly assigned to receive either the OsciPulse system or standard therapy within 24 hours of admission to the neuro ICU. The treatment will continue for up to 7 days, with daily monitoring of d-dimer levels. An interim analysis will be conducted after 20 subjects to evaluate enrollment speed and data quality.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older admitted to the neuro ICU with a diagnosis of ischemic stroke and prescribed mechanical therapy for DVT prophylaxis.
Not a fit: Patients with contraindications to applying intermittent pneumatic compression or those with severe lower extremity conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective method for DVT prophylaxis in patients with ischemic stroke.
How similar studies have performed: Other studies have shown promise in using similar mechanical therapies for DVT prevention, but this specific approach with the OsciPulse system is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult aged ≥ 18 years old 2. Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke 3. \< 24 hours from last known normal or treating-hospital admission. 4. NIH stroke score ≥5 5. Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores) 6. Prescribed mechanical therapy for DVT prophylaxis. Exclusion Criteria: 1\. 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.
Where this trial is running
Philadelphia, Pennsylvania
- HUP Neurology Dept. of Stroke and Neurocritical Care- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Steven Messe, MD — University of Pennsylvania
- Study coordinator: Steven Messe, MD
- Email: Steven.Messe@pennmedicine.upenn.edu
- Phone: 215-662-3363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.