DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of Participants With Post-operative Wound Complications
研究概览
简要总结
This trial studies how well dalteparin works in preventing deep vein thrombosis (DVT) (blood clots) in participants with cancer. Dalteparin is a blood thinner that can treat blood clots and may prevent them from forming.
详细描述
PRIMARY OBJECTIVES:
I. To determine the safety of dalteparin as prophylaxis against deep venous thrombosis (DVT) in orthopedic oncology patients.
II. To determine whether there are significantly increased bleeding complications at the surgical site after major oncologic operations in the lower extremity.
OUTLINE:
Participants receive dalteparin subcutaneously (SC) once daily (QD) starting 12-24 hours after surgery on post-operative day 1 until hospital discharge, about 7-10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic disease, myeloma, lymphoma.
- •Pathologic fracture or impending pathologic fracture of the femur.
- •Intramedullary rod, plating, cementation, hip arthroplasty, or knee arthroplasty.
- •Primary sarcoma of bone or soft tissue of the lower extremity.
- •T2 tumor (> 5 cm by < 20 cm).
- •Radical resection of tumor, which may necessitate major bone or soft tissue reconstruction.
排除标准
- •Presence of DVT on pre-operative screening ultrasound study.
- •Massive tumor (> 20 cm in greatest dimension).
- •Amputation of the affected leg as treatment of tumor.
- •Estimated blood loss > 2 liters during surgery.
- •Surgical drain output > 500 cc of bloody fluid during first 8 hours.
- •International normalized ratio (I.N.R.) > 1.3 pre-operatively or > 1.5 post-operatively.
- •Platelet count < 100,000 either pre-operatively or post-operatively.
- •Indwelling post-operative epidural catheter for pain control.
- •History of underlying bleeding disorder, such as hemophilia.
- •History of adverse reaction to heparin such as heparin-induced thrombocytopenia.
- •Severe liver or renal insufficiency.
- •History of hypertensive or diabetic retinopathy.
- •History of gastro-intestinal bleeding within 12 months.
- •Treatment with warfarin, clopidogrel, aspirin, nonsteroidal antiinflammatory drugs (NSAIDs), low molecular weight heparin (LMWH) or other anti-coagulants for conditions.
- •History of stroke.
- •Women of child bearing potential having a positive urine or serum pregnancy test (human chorionic gonadotropin [hCG]) at the time of pre-operative evaluation (within 7 days of surgery).
- •Women who are breastfeeding.
- •Hemoglobin < 8.0 g/dL.
- •Platelet count < 100,000/L.
- •Alanine aminotransferase > 100 IU/L.
- •Aspartate aminotransferase > 100 IU/L.
- •Direct bilirubin > 0.5mg/dL.
- •Serum creatinine > 2.0 mg/dL.
- •Patients taking COX-2 inhibitors.
- •Patients who have fragmented mechanical heart valves.
研究组 & 干预措施
Treatment (dalteparin)
Participants receive dalteparin SC QD starting 12-24 hours after surgery on post-operative day 1 until hospital discharge, about 7-10 days.
干预措施: Dalteparin (Drug)
结局指标
主要结局
Number of Participants With Post-operative Wound Complications
时间窗: 4 weeks after surgery
Our primary outcome was the incidence of post-surgical complications, to include wound dehiscence, infection, and seroma.
次要结局
- Post-Operative Blood Transfusion(4 weeks after surgery)
- Number of Participants With Occurrence of Venous Thromboembolism(4 weeks after surgery)