Phase II Study of Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- all cause DVT
研究概览
简要总结
Deep vein thrombosis (DVT) remains a life-threatening complication of arthroplasty. It remains controversial for anticoagulation strategies after total hip arthroplasty (THA). A randomized double-blind study was conducted to determine whether prophylactic anticoagulation was efficient reduce DVT after THA. subjects who underwent uncemented THA were assigned to prophylactic anticoagulation group or non- prophylactic anticoagulation group. Patients were followed up 3 months later after surgery. DVT was tested by contrast venography. Investigator also used logistic regression analysis with variable selection for obtaining the prediction model of DVT. DVT after THA was affected by personal (age) and clinical factors (mechanical compression, duration of surgery). THA with short duration of surgery did not require prophylactic anticoagulation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary total hip arthroplasty
排除标准
- •Revision hip replacement, total knee replacement, revision knee replacement, semi-hip replacement and cemented THR were excluded.
- •Coagulation related disease and cancer were excluded either.
结局指标
主要结局
all cause DVT
时间窗: 7 days
deep-vein thrombosis nonfatal pulmonary embolism, or death
次要结局
- Major DVT(7 days)
研究者
JIANG Qing
Director, The Center of Diagnosis and Treatment for Joint Disease
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School