Prophylaxis of Thromboembolism in Critically Ill Patients Using Combined Intermittent Pneumatic Compression(IPC) and Pharmacologic Prophylaxis Versus Pharmacologic Prophylaxis Alone: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Proximal deep vein thrombosis(DVT) diagnosed by compression ultrasound
研究概览
简要总结
Patients admitted to the intensive care unit are at high risk of developing clots in the veins of the lower extremities. The objective of this study is to examine whether the use of a device that provides intermittent compression to the legs in addition to the use of low-dose blood thinners, provides an additional protection when compared to the use of blood thinners alone. Patients who are admitted to the intensive care unit are receiving low-dose blood thinners to prevent clots are candidates for this study. Patients who are enrolled will continue to receive blood thinners but some will additionally receive the leg compression. The additional use of leg compression may provide protection from clots. The main side effect is possible skin abrasions but this is usually mild. The study is sponsored by King Abdullah International Medical Research Center(KAIMRC) and King Abdulaziz City for Science and Technology(KACST) and will be conducted in several hospitals in Saudi Arabia, Canada, Australia, Brazil and possibly other countries. The study started July 2014 and is to continue for 4 years.
详细描述
There is no randomized controlled trial examining effect of the adjunct use of IPC with pharmacologic prophylaxis compared to pharmacologic prophylaxis (UFH, LMWH) alone in critically ill patients for VTE prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intermittent Pneumatic Compression(IPC)
The intervention group will be receiving Intermittent Pneumatic Compression(IPC)
干预措施: pneumatic compression (Device)
No Intermittent Pneumatic Compression
patients will not receive Intermittent Pneumatic Compression
结局指标
主要结局
Proximal deep vein thrombosis(DVT) diagnosed by compression ultrasound
时间窗: 28 days from randomization
The primary outcome is incident proximal leg DVT, defined as detected 3 or more days post-randomization and up to ICU discharge or day 28 post randomization
次要结局
- Pulmonary Embolism(from the time of randomization to 90 days)
研究者
Dr Yaseen Arabi
Chairman, Intensive Care Department
King Abdulaziz Medical City
