NCT01935414已完成不适用
A Multicentre Randomised Controlled Trial Comparing the Incidence of Asymptomatic and Symptomatic Deep Vein Thrombosis Between the gekoTM Device and Thromboembolism Deterrent Stockings in Patients Recovering From Total Hip Replacement Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Presence of asymptomatic DVT assessed by Duplex Ultrasound
研究概览
简要总结
This study hypothesises that the geko™ device is more efficient than TEDS in preventing the formation of symptomatic/asymptomatic Deep Vein Thrombosis (DVTs), post-surgery.
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
- 否
入选标准
- •Aged 18 years of age and over
- •Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders).
- •Has not used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator during the ten (10) days preceding enrolment.
- •Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
- •Able and willing to follow the protocol requirements.
排除标准
- •Are requiring hip revision surgery
- •History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
- •Evidence of asymptomatic DVT by Duplex Ultrasound
- •Peripheral arterial disease (ABPI < 0.8), varicose veins or lower limb ulceration or ischemia.
- •Significant varicose veins, phlebitis or lower limb ulceration or ischemia. CEAP Grade 4-
- •See Appendix 2
- •Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).
- •Recent trauma to lower limb.
- •Chronic Obesity (BMI Index >40kg/m2).
- •Significant history of following diseases I. Cardiovascular: Recent MI (< 6 months) II. Percutaneous Coronary Intervention (PCI) with stent (< 3 months for Bare Metal Stent (BMS) and < 12 months for Drug Eluding Stent (DES) III. Moderate to severe CCF, uncontrolled AF IV. Neurological: Stroke, Hemiplegia/Paraplegia, Myopathies V. Significant dermatological conditions affecting lower limbs resulting in broken or inflamed skin particularly at the site where the device is to be fitted.
- •VI. Clinically significant haematological conditions i.e. coagulation disorders, sickle cell disease VII. Psychiatric disorders
- •On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin
- •Long term steroid with dermatological changes
- •A pulse rate of less than 40 beats/minute
- •A sitting systolic blood pressure >180 and <100 mmHg and/or a sitting diastolic pressure of >100 mmHg.
- •Any significant illness during the four (4) weeks preceding the hip replacement surgery.
- •Participation in any clinical study during the eight (8) weeks preceding the screening period
结局指标
主要结局
Presence of asymptomatic DVT assessed by Duplex Ultrasound
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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