跳至主要内容
临床试验/NCT04232501
NCT04232501撤回不适用

Effect of Novel Sequential Compression Device on the Incidence of Deep Venous Thrombosis on Complex Surgical Spine Patients

Stanford University2 个研究点 分布在 1 个国家开始时间: 2021年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Incidence of Deep Vein Thrombosis (DVT)

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of a new leg compression device in preventing post-surgical deep vein thrombosis (blood clot) that can occur after major and complex spine surgery. The investigators aim to show that this new compression device is no worse than the standard sequential compression device (SCD) at preventing DVT and may be able to detect deep vein thrombosis in patients who are not typically screened for this diagnosis after surgery. This new device may be able to capture an important post-surgical complication while providing a more comfortable treatment option.

详细描述

Compression therapy of the leg is a proven and well-established modality to prevent deep vein thrombosis in immobilized and post-surgical patients. The investigators aim to compare a new sequential compression for the leg that utilizes a servo motor for compression as opposed to a traditional pneumatic motor that is typically used in the hospital and after surgery. Pneumatic sequential compression devices are cumbersome, expensive and not mobile. This new compression device was developed to provide a cheaper, mobile device that can be worn by the patient after surgery and while at home during ambulation. The addition of the servo motor and fine sensors may also be able to detect sub-clinical DVT's that contribute to post-surgical pulmonary embolus and post-surgical complications. The investigators aim to learn how this new device performs in the subset of patients undergoing complex spine surgery, the incidence of post-surgical DVT with this new device compared to traditional SCD and if this new device is capable of detecting sub-clinical post-surgical DVT.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for complex spine surgery at Stanford Hospital

排除标准

  • Pregnancy
  • Non-decisional capacity
  • Incarcerated persons
  • Any hereditary or acquired coagulopathy

结局指标

主要结局

Incidence of Deep Vein Thrombosis (DVT)

时间窗: Within four weeks after surgery

Number of participants with DVT diagnosed by ultrasound after complex spine surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Schlifke

Clinical Assistant Professor, Anesthesia

Stanford University

研究点 (2)

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