Ischemic Stroke
Conditions
Brief 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.
Detailed description
This is a single site, randomized open label two arm study. The patient population will be randomly divided into two arms, with one receiving the OsciPulse System and the other receiving standard intermittent compression therapy. Both arms will have the therapy applied within 24 hours of admission and continue during their hospital stay until day 7 or discharge, whichever is shorter, unless clinically required to be removed. Daily d-dimer levels will be assessed until day 7 or discharge. If required beyond day 7, standard compression therapy will be provided. An interim analysis will be performed after 20 subjects are enrolled to evaluate the speed of enrollment and data variability and quality. If indicated, enrollment will be increased up to 40.
Interventions
DEVICEOsciPulse
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.
Sponsors
University of Pennsylvania
OsciFlex LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single site, randomized open label two arm study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum d-dimer levels. | 7 days | Relative change in serum d-dimer levels for each subject from baseline to Day 7 or discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of the OsciPulse device in the stroke population | 7 days | Tolerability defined as the number of patients who stop using the device prior to clinical recommendation and by quantitative scoring of subject experience questionnaires. |
| Safety of the OsciPulse device in the stroke population | 7 days | Comparison of the rate of Adverse Events (AE) between the two groups. |
Countries
United States
Contacts
CONTACTSteven Messe, MD
CONTACTSophia Bautista
PRINCIPAL_INVESTIGATORSteven Messe, MD
University of Pennsylvania
Outcome results
None listed