Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Blood Loss
研究概览
简要总结
This is a prospective, randomized study from pre-surgery to 6 weeks post-surgery designed to detect changes in coagulability following elective total knee and hip arthroplasty. Patients will be randomized to one of the two standard prophylaxis treatments used at Sinai Hospital:
- Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks, or
- Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Men or women age ≥ 18 years old
- •Total knee or total hip arthroplasty planned in the 60 days following study enrollment
排除标准
- •Pre-existing anti-coagulant therapy (Heparin, Lovenox, Arixtra, Warfarin, Xarelto, and all other non-mentioned anticoagulants) on admission
- •History of bleeding diathesis
- •Known active malignancy
- •Prothrombin time >1.5 x control
- •Platelet count < 100,000/mm3, hematocrit < 30%, creatinine clearance <30 mL/min
- •Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, Bacterial endocarditis
- •Major surgery within past 3 months of enrollment
- •Patients requiring bilateral arthroplasty
- •Body weight <50 kg (venous thromboembolism prophylaxis only)
- •Unable to return to site for follow-up visit
研究组 & 干预措施
Arixtra Arm
Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
干预措施: Aspirin (Drug)
Arixtra Arm
Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
干预措施: Arixtra (Drug)
Pneumatic compression stockings arm
Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
干预措施: Pneumatic compression stockings (Device)
Pneumatic compression stockings arm
Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
干预措施: Aspirin (Drug)
结局指标
主要结局
Blood Loss
时间窗: 6 weeks
requiring transfusion
次要结局
- Deep Vein Thrombosis(6 weeks)