A Prospective Study in Chinese Patients With Lower Extremity Ankle Fracture of Oral Anticoagulants to Prevent Venous Thromboembolism (VTE)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- the rate of venous thromboembolism (VTE) on 12th postoperative week
研究概览
简要总结
Deep vein Thrombosis (Deep Venous Thrombosis, DVT) and Pulmonary Embolism, Pulmonary Embolism, PE) both collectively known as Venous thromboembolism (VTE) (Venous Thrombus Embolism, VTE), is a common clinical disease, and tremendous harmful. Ankle fractures in patients requiring long-term bed braking, increase the incidence of lower extremity deep vein thrombosis, anticoagulant therapy as an important measures to prevent thrombosis in clinical widely accepted, however, the literature anticoagulation effect incision healing. Whether to strike a balance between the two, to develop a foot fracture in accordance with the Chinese characteristics of anticoagulant solution is we try to solve the problem. The purpose of this study is aimed at the use of oral anticoagulants and physical anticoagulant treatment knee far foot fracture patients randomized controlled studies in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) year full 18 one full year of life (2) one side of ankle fractures, calcaneal fractures, the metatarsal bone fracutures will use the internal fixation treatment 3) participants must be able to normal conversation, and understand the problems in the "subject subjective questionnaire", and could provide feedback using the appropriate language.
排除标准
- •Subjects did not provide a voluntary agreement 2) subjects participating in clinical research for pregnant or lactating women 3) has preoperative examination in the diagnosis of venous thromboembolism (VTE) 4) in patients with preoperative oral antiplatelet/anticoagulation drugs for a long time.
- •surgery time fractures occur over time more than 3 weeks 6) patients exist pilon fractures (AO type 43-43 - B and C) and ankle multiple fractures, 7) pathological fractures (e.g., primary or metastatic tumors) 8) severe soft tissue injuries, open fractures or vascular injury or the combining bone fascia room syndrome; 9) multiple injuries, judge doesn't fit into the study by researchers, and other parts of the three or more than fracture 10) revision surgery (e.g., malunion, bone nonunion or infection) 11) merger of anticoagulant taboo disease, judge doesn't fit into the study by researchers, such as the active bleeding and clotting disorders, severe head trauma or acute spinal cord injury, platelet count < 20 ╳ 109 / L, etc.; 12) patients with anesthesia and surgery patients with contraindications to 13) on pp shaaban drug allergy 14) patients may be poor compliance, the researchers determined doesn't fit into the daily (such as excessive drinking or smoking, taking drugs) 15) patients in the past three months participated in other clinical trials; 16) in patients with poor compliance, judge not according to the study by the researchers plan to complete the test, such as schizophrenia and dementia
研究组 & 干预措施
Apixaban
干预措施: Apixaban Oral Tablet (Drug)
Placebo
干预措施: Apixaban Oral Tablet (Drug)
结局指标
主要结局
the rate of venous thromboembolism (VTE) on 12th postoperative week
时间窗: 12th postoperative week
For individual subjects, if after 12 weeks to satisfy all of the following conditions, is considered an effective means to test: 1. The local infection, wound dehiscence, bleeding and swelling, local no abnormal activities; 2. Confirmed by doppler ultrasound has no lower limb venous thromboembolism (VTE); 3. No serious adverse events.
次要结局
未报告次要终点