A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in serum d-dimer levels.
研究概览
简要总结
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.
详细描述
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.
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 —（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
- •< 24 hours from last known normal or treating-hospital admission.
- •NIH stroke score ≥5
- •Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores)
- •Prescribed mechanical therapy for DVT prophylaxis.
排除标准
- •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
- •Subjects who received thrombolytic therapy for their stroke
- •Known 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 within 24 hours of study enrollment.
- •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
Change in serum d-dimer levels.
时间窗: 7 days
Relative change in serum d-dimer levels for each subject from baseline to Day 7 or discharge
次要结局
- Tolerability of the OsciPulse device in the stroke population(7 days)
- Safety of the OsciPulse device in the stroke population(7 days)