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临床试验/NCT02040103
NCT02040103已完成不适用

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

King Abdullah International Medical Research Center2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2014年7月16日最近更新:
适应症
干预措施

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

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)

Experimental

The intervention group will be receiving Intermittent Pneumatic Compression(IPC)

干预措施: pneumatic compression (Device)

No Intermittent Pneumatic Compression

No Intervention

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

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

Dr Yaseen Arabi

Chairman, Intensive Care Department

King Abdulaziz Medical City

研究点 (2)

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