Observational Cohort Study on the Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,676
- 试验地点
- 53
- 主要终点
- Occurrence of Symptomatic Venous Thromboembolic Events
研究概览
简要总结
Observational cohort study on the prevention of venous thromboembolic events after elective orthopaedic surgery for Total Knee Replacement or Total Hip Replacement iin patients treated with PRADAXA to evaluate the efficacy ant safety of Pradaxa in real-life conditions
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Occurrence of Symptomatic Venous Thromboembolic Events
时间窗: 11 weeks
Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE).
Occurrence of Major Bleeding Events
时间窗: 11 weeks
Occurrence of major bleeding events (MBEs) in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either THR or TKR surgery). MBEs were defined as any fatal haemorrhage, any overt bleeding greater than could be expected combined with a loss of haemoglobin ≥ 2 g/dL or requiring transfusion ≥ 2 packed red blood cells units (PRBC), any symptomatic retroperitoneal, intracranial, intraocular or intraspinal haemorrhage or any bleeding requireing treatment cessation or reoperation. a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary emboliam (PE).
次要结局
- Reasons for Nurse Visits on the Day of Hospital Discharge(11 weeks)
- Concomitant Treatments(11 weeks)
- Adherence to Treatment(11 weeks)
- Proportion of Patients With a Preoperative ALT Measurement(11 weeks)
- Duration of Treatment(11 weeks)
- Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge(11 weeks)
- Frequency of Nurse Visits on the Day of Hospital Discharge(11 weeks)
- Duration of Unplanned Hospitalizations at Visit 3(11 weeks)
- Dosage of Pradaxa at Initiation(Baseline)
- Duration Between Surgery and First Dose of Pradaxa(11 weeks)
- Number of Patients Who Switched to Another Anticoagulant Therapy(11 weeks)
- Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge(11 weeks)
- Reasons for Unplanned Hospitalizations at Visit 3(11 weeks)
- Reasons for Usual Follow-up(11 weeks)