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| Name | Class |
|---|---|
| OsciFlex LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A-OsciPulse System | Experimental | Patients admitted to the neuro intensive care unit or intermediate neurological care unit with a diagnosis of ischemic stroke randomly assigned to Group A. |
|
| Group B- Standard Reference Therapy | Active Comparator | Patients admitted to the neuro intensive care unit or intermediate neurological care unit with a diagnosis of ischemic stroke randomly assigned to Group B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsciPulse | Device | Non-invasive device that provides rapid pulses of compression of the calves to modify venous blood flow patterns in immobilized persons. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum d-dimer levels. | Relative change in serum d-dimer levels for each subject from baseline to Day 7 or discharge | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of the OsciPulse device in the stroke population | Tolerability defined as the number of patients who stop using the device prior to clinical recommendation and by quantitative scoring of subject experience questionnaires. | 7 days |
| Safety of the OsciPulse device in the stroke population |
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Inclusion Criteria:
Exclusion Criteria:
1. Inability or contraindication to applying IPC to both legs such as:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Messe, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUP Neurology Dept. of Stroke and Neurocritical Care- University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D048228 | Intermittent Pneumatic Compression Devices |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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Single site, randomized open label two arm study.
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| Intermittent Pneumatic Compression | Device | Non-invasive device that provides rapid pulses of compression of the calves to modify venous blood flow patterns in immobilized persons. |
|
Comparison of the rate of Adverse Events (AE) between the two groups. |
| 7 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |