OsciPulse D-dimer Efficacy Trial

OsciFlex

Status and phase: Withdrawn; Phase 2

Conditions: Ischemic Stroke; Venous Thromboses

Treatments: Device: Flowtron ACS900; Device: OsciPulse system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05389488

OSC-VTE-003

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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. Last known normal < 24 hours.
4. NIH stroke score ≥5
5. Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores, items 6A and 6B)
6. Prescribed mechanical therapy for DVT prophylaxis.

Exclusion criteria

1. 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

2. Subjects who received tPA therapy for their stroke

3. 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 for the first 24 hours or more

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Control Arm

Active Comparator group

Description:

Subjects will receive standard of care intermittent compression therapy using the current devices used in the clinical space.

Treatment:

Device: Flowtron ACS900

Study Arm

Experimental group

Description:

Subjects will receive compression therapy from the OsciPulse system.

Treatment:

Device: OsciPulse system