The Effect of Intraoperative Sequential Compression Devices on Fibrinolysis in Plastic Surgery Outpatients: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in plasma levels of tissue plasminogen activator and plasminogen activator inhibitor-1
研究概览
简要总结
This study investigates a possible fibrinolytic effect of sequential compression devices (SCDs). These devices have been used for decades to reduce risk of deep venous thrombosis (DVT). However, a randomized study in plastic surgery outpatients has not been done. This study is undertaken to remedy that deficiency in our knowledge base.
详细描述
Protocol: The Effect of Intraoperative Sequential Compression Devices on Fibrinolysis in Plastic Surgery Outpatients
- Study Synopsis
Deep venous thrombosis (DVT) is a serious and potentially life-threatening surgical complication. Sequential compression devices (SCDs), also called intermittent pneumatic compression, are widely used by surgeons in an effort to reduce risk. In addition to a possible mechanical effect, some investigators believe that these devices reduce the coagulability of blood by altering the fibrinolytic balance. This investigation is meant to evaluate any possible effect of these devices on fibrinolytic activity.
The SCDs are not being investigated for a new indication. This study is meant to determine whether these commonly used devices have any effect on blood coagulability. This study is not intended to determine whether SCDs affect DVT rates. 2. Background
The investigator (ES) has conducted a literature search on this topic. There is no published prospective randomized study available investigating a possible fibrinolytic effect of SCDs in surgical patients. Therefore any clinical benefit remains speculative. 3. Objective
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
- 是
入选标准
- •All healthy patients aged 18 or more.
排除标准
- •These conditions include suspected active or untreated DVT, pulmonary edema, congestive heart failure, thrombophlebitis or an active infection, vein ligation, gangrene, dermatitis, open wounds, a recent skin graft, massive edema or extreme deformity of the leg, neuropathy, legs that are insensitive to pain, or when increased venous or lymphatic return is undesirable.
研究组 & 干预措施
Sequential compression devices
Sequential compression devices (SCDs) are applied during surgery.
干预措施: Sequential compression devices (SCDs) (Procedure)
No sequential compression devices
No sequential compression devices are applied.
干预措施: No sequential compression. (Procedure)
结局指标
主要结局
Change in plasma levels of tissue plasminogen activator and plasminogen activator inhibitor-1
时间窗: 1-2 months
Laboratory testing of serum levels
次要结局
未报告次要终点