Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty (THA): Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 411
- 试验地点
- 9
- 主要终点
- Events of Deep Vein Thrombosis (DVT)
研究概览
简要总结
Evaluation of the safety and effectiveness of ActiveCare+ CECT device +/- baby dose aspirin (81 mg QD) for lowering the potential risk for bleeding and of DVT during and after THA surgery in comparison with LMWH.
详细描述
Patients undergoing total hip arthroplasty surgery are at particular risk for Thromboembolic disease. To date two prophylactic modalities are being used: mechanical (intermittent pneumatic compression [IPC]) and pharmacological (anticoagulant). Both are effective; however each carries its own advantages and disadvantages.
The purpose of this study is to compare in total hip arthroplasty (THA) patients the safety and effectiveness of the mobile ActiveCare CECT based prophylaxis protocol and compare it with LMWH standard of care protocol for this patient population.
The protocol is based upon the CECT system as the primary DVT prophylaxis method (with or without the addition of low dose baby aspirin [81 mg]).
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
- Single (Outcomes Assessor)
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
- •Adult patient (Age >18). Patient intended to undergo elective primary unilateral THA surgery. Patient is able and willing to follow instructions of care after surgery. Patient is able and willing to sign the institution human subjects committee approved Informed Consent Form.
排除标准
- •Patient who has a known coagulation disorder. Patient currently treated with anticoagulant medications. Patient with known thrombophilia Patient with current signs and symptoms of or history of DVT/PE. Patient who is uncooperative or unable to follow instructions. Patient currently suffering from a solid tumor malignancy. Patient with active peptic disease. Patient with known allergy to baby aspirin (81 mg) or enoxaparin. Patient with contraindication to use of the device including patients with leg gangrene, recent skin graft or medical situations where increase venous and lymphatic return is undesirable.Patient has major surgery procedure within 3 months prior to the study surgery, or patients with a major surgery procedure planning during the study period.Pregnant women.Patient who is participating in another clinical drug trial.
研究组 & 干预措施
ActiveCare CECT
The ActiveCare CECT device is a mobile compression device used to prevent venous thromboembolic events, used after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery.
干预措施: ActiveCare CECT device (Device)
LMWH (Enoxaparin)
Enoxaparin (LMWH) will be used, following a protocol that is considered a standard of care for this patient population. 40mg QD for the remainder of the 10 days.
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Events of Deep Vein Thrombosis (DVT)
时间窗: 10-12 days post-op; and from day of surgery and up to 3 months if symptomatic
10-12 days post-op: All of the patients underwent Routine bilateral compression Doppler. Day of surgery and up to 3 months post-op: Suspected clinical signs and symptoms DVT events were confirmed by standard diagnostic objective methods
Clinical PE (Pulmonary Embolism) Events
时间窗: Day of surgery and up to 3 months
Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT
次要结局
- Major Bleeding Complication(Up to 30 days)
- Serious Adverse Events(SAE data were collected Up to 3 months post-op)
- OutPatient Patients' Compliance(10-12 days post-op)
- In-Patients' Compliance(Surgery till discharge)