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临床试验/NCT04341272
NCT04341272已完成不适用

Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis: A Pilot Randomized Trial

Baltimore VA Medical Center0 个研究点目标入组 106 人开始时间: 2014年4月1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
106
主要终点
venous thromboembolic event following surgery

研究概览

简要总结

Venous thromboembolism (VTE) is an important cause of morbidity and mortality following surgery.A combination of chemical and mechanical prophylaxis using lower extremity compression devices (CD) is recommended in patients who are considered at 'moderate risk' (Caprini score 2 - 4) or 'high risk' (Caprini score > 4) of developing VTE.

The aim of this study was to determine whether upper extremity (UE) CD are as effective as lower extremity (LE) CD in preventing VTE following surgery. A total of 106 patients were recruited.

详细描述

Hospitals throughout the United States currently utilize mechanical compression devices on patients' limbs for prevention of blood clots, in addition to blood thinning medication - heparin. The compression devices act by affect blood clotting mechanism and there is evidence from previous research studies that blood is less likely to develop clots when these compression devices are placed on the arms or legs.

The use of compression devices on arms and legs is within standard of care, but use on legs tends to be more common.

Research studies have shown that use of compression devices in combination with heparin is more effective in preventing blood clots than either one alone.

Not many clinicians remember the option of placing compression devices on arms, and patients who do not get compression devices placed on their legs following surgery, often get only medication (heparin) with no compression device placed at all.

This study will compare the effectiveness of compression devices used on patients' arms with those used on patients' legs, at preventing blood clots. Non-invasive ultrasound studies will be used after surgery to check for blood clots in the legs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •Males aged > 18 years who could provide informed consent

排除标准

  • •Patients on coumadin or post-operative therapeutic heparin
  • •Known history of venous thromboembolism (VTE)
  • •Known history of hematological disorders
  • •Diagnosed malignancy requiring or undergoing treatment
  • •Presence of upper extremity arterio-venous access for hemodialysis
  • •Females were excluded to eliminate the confounding thrombogenic effect of estrogen.

研究组 & 干预措施

Upper Extremity Compression Device

Active Comparator

Patients randomized to have pneumatic compression device placed on upper extremity following surgery

干预措施: Intermittent Pneumatic Compression Device (FDA approved) (Device)

Control

Other

Patients randomized to have pneumatic compression device placed on lower extremity following surgery

干预措施: Intermittent Pneumatic Compression Device (FDA approved) (Device)

结局指标

主要结局

venous thromboembolic event following surgery

时间窗: within 45 days following surgery

venous thrombosis (VT) or pulmonary embolism (PE): number of screening lower extremity venous duplex ultrasound studies showing VT and any CT scans showing PE in symptomatic patients

次要结局

未报告次要终点

研究者

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

Preeti R. John, MD, MPH, FACS

Clinical Assistant Professor

Baltimore VA Medical Center

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