A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- OsciFlex LLC
- 试验地点
- 2
- 主要终点
- Relative change in serum d-dimer levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Relative change in serum d-dimer levels
时间窗: 7 days
We will measure the change in serum d-dimer levels over time as a marker of venous coagulation.
次要结局
- Device tolerability(7 days)