Extended Deep Venous Thrombosis Prophylaxis in Gynecologic Oncology Surgery With Intermittent Compression Devices (ICD) With or Without Postoperative Arixtra (Fondaparinux Sodium): A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra
研究概览
简要总结
This is a randomized trial to compare intermittent compression devices with or without post-operative Arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for known or presumed gynecologic malignancies. This trial seeks to determine if there is a difference in the rate of deep venous thrombosis between these two groups.
详细描述
To assess the effectiveness of Arixtra (fondaparinux sodium) in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic 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
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All patients undergoing open laparotomy (non-laparoscopic) gynecologic surgery.
- •Patients must be competent to self-administer injections, or must have caregivers or nurses who can perform injections
- •Patients must have signed an approved informed consent
排除标准
- •Patients with medical history which requires chronic anticoagulation (i.e. previous DVT, pulmonary embolism, atrial fibrillation, heart valve replacement)
- •Patients with contraindications to anticoagulation (generalized bleeding disorders, peptic ulcer disease, hemorrhagic stroke, etc)
- •Contraindications to placement of ICDs (history of lower extremity venous stasis ulcers)
- •Patients receiving low molecular weight heparin or unfractionated heparin for prophylaxis post-operatively
- •Patients who are unable to receive injections as an outpatient and/or unable to undergo a doppler ultrasound of the lower extremities
- •Renal insufficiency (creatinine clearance < 30 mL/min)
- •Patients who have a body weight < 50 kg
- •Hypersensitivity to low molecular weight heparin
- •Patients who are pregnant or have a positive pregnancy test.
- •Patients receiving continuous (indwelling) epidural.
研究组 & 干预措施
Intermittent compression devices (ICD)
All patients will receive intermittent compression devices (ICD's) during the patient's entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
干预措施: Intermittent compression devices (ICD) (Device)
Arixtra (fondaparinux sodium)
Patients randomized to treatment arm will initiate Arixtra (fondaparinux sodium) treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization time and after hospital discharge).
干预措施: Arixtra (fondaparinux sodium) (Drug)
结局指标
主要结局
Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra
时间窗: 21 days
Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.
次要结局
- Incidence of Untoward Effects With Arixtra(21 days)
研究者
Warner Huh
Principal Investigator
University of Alabama at Birmingham