A Randomized Controlled Trial Comparing Apixaban Versus Enoxaparin Following Microsurgical Breast Reconstruction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Apixaban vs. Enoxaparin - Number of Participants With Bleeding Events
研究概览
简要总结
Subcutaneous enoxaparin is currently the gold standard for VTE chemoprophylaxis. However, the efficacy of chemoprophylaxis with subcutaneous enoxaparin is affected by patient-level factors, thus, resulting in VTE events despite guideline-compliant prophylaxis. A population at particular risk is the growing number of patients who undergo autologous breast reconstruction. Direct oral anticoagulants (DOAC) might be a less invasive, yet, more efficacious mode of chemoprophylaxis in this patient population. Hence, the proposed work has the potential to cause a paradigm shift in chemoprophylaxis guidelines in a large population of patients undergoing plastic 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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult (>18 years) women
- •Scheduled to undergo unilateral or bilateral microsurgical breast reconstruction with free abdominal flaps (i.e. muscle-sparing transverse rectus abdominis musculocutaneous [TRAM] and/or deep inferior epigastric artery perforator [DIEP]) flap)
- •Caprini score of 6 or greater.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Contraindication to the use of apixaban or enoxaparin
- •Active bleeding
- •History of bleeding disorder
- •History of coagulopathy
- •History of heparin-induced thrombocytopenia
- •History of liver disease
- •History of renal disease (creatinine clearance <30 mL/min; serum creatinine >1.6 mg/dL)
- •Major neurosurgical intervention (brain/spine) within the past 90 days
- •Ophthalmologic procedure within the past 90 days
- •Uncontrolled hypertension
- •History of alcohol and/or substance abuse
- •Need for therapeutic anticoagulation
- •Pregnant or Nursing
研究组 & 干预措施
Apixaban
Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure.
干预措施: Apixaban 2.5 MG Oral Tablet (Drug)
Enoxaparin
Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure.
干预措施: Enoxaparin 40Mg/0.4mL Prefilled Syringe (Drug)
结局指标
主要结局
Apixaban vs. Enoxaparin - Number of Participants With Bleeding Events
时间窗: 90-day events
To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction
次要结局
- Apixaban vs. Enoxaparin - Number of Participants With Venous Thromboembolism (VTE) Events(90 days)
研究者
Arash Momeni
Assistant Professor of Surgery (Plastic Surgery)
Stanford University