OsciPulse D-dimer Efficacy Trial

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of the OsciPulse System in reducing serum d-dimer levels in hospitalized ischemic stroke patients.

Detailed Description
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After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Eligible and enrolled patients who have been admitted to the hospital for an ischemic stroke will be randomized in a non-blinded study to receive compression therapy from either standard-of-care intermittent compression garments, or the OsciPulse System. During the duration of the subject's hospital stay serum d-dimer levels will be monitored serially.

Official Title
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A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer

Conditions
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Venous Thromboses, Ischemic Stroke

Intervention / Treatment
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* Device: OsciPulse system
* Device: Flowtron ACS900


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult aged ≥ 18 years old Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke Last known normal < 24 hours. NIH stroke score ≥5 Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores, items 6A and 6B) Prescribed mechanical therapy for DVT prophylaxis. Exclusion Criteria: Inability or contraindication to applying IPC to both legs such as: Evidence of bone fracture in lower extremities Burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis, ischemic limb in the legs at the site of IPC placement Acute ischemia in the lower extremities Severe peripheral vascular disease Amputated foot or leg on one or two sides Compartment syndrome Severe lower extremity edema Acute deep vein thrombosis Subjects who received tPA therapy for their stroke Pregnancy or within 6 weeks of postpartum period Limitation of life support, life expectancy < 7 days, or in hospice care A head-unit is unavailable for the first 24 hours or more 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Arm<br>Subjects will receive standard of care intermittent compression therapy using the current devices used in the clinical space. | Device: Flowtron ACS900<br>* The Arjo Flowtron ACS900 intermittent pneumatic compression system provides compression the calf to augment venous blood flow.<br>|
| Experimental: Study Arm<br>Subjects will receive compression therapy from the OsciPulse system. | Device: OsciPulse system<br>* The OsciPulse system is a pneumatic compression system designed to provide intermittent compression to the limbs to augment venous blood flow.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change in serum d-dimer levels | We will measure the change in serum d-dimer levels over time as a marker of venous coagulation. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device tolerability | We will measure the number of patients that are compliant with the treatment and quantify their experience with a questionnaire. | 7 days |