Observational Cohort Study to Evaluate the Safety and Efficacy of Switching From Lovenox (Enoxaparin) 40mg to Pradaxa (Dabigatran Etexilate) 220mg in Patients Undergoing Elective Total Hip or Knee Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 167
- 试验地点
- 7
- 主要终点
- Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period
研究概览
简要总结
an open, prospective, observational study to collect data on safety (major bleeding events) and efficacy (symptomatic venous thromboembolism(VTE)) of a switch from Enoxaparin to dabigatran etexilate in patients with total knee replacement (TKR) and total hip replacement (THR)
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 99 Years（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
研究组 & 干预措施
patients after hip or knee replacement
干预措施: dabigatran (Drug)
结局指标
主要结局
Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period
时间窗: From last enoxaparin administration until 24 hours after last Pradaxa intake( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)
Major bleeding events were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin \>=20g/L in excess of what was expected; clinically overt leading to the transfusion of \>=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation.
Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All-cause Mortality Events During the Switch-/ Post-switch Treatment Period
时间窗: From last enoxaparin administration until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)
sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).
次要结局
- Percentage of Patients With sVTE and All-cause Mortality Events During Total Treatment Period(From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed)
- Percentage of Patients With MBE During Total Treatment Period(From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed)
- Percentage of Patients With MBE During Pre-switch Treatment Period(From first enoxaparin administration until last enoxaparin administration)
- Percentage of Patients With sVTE and All-cause Mortality Events During Pre-switch Treatment Period(From first enoxaparin administration until last enoxaparin administration)
- Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period(From last enoxaparin administration until first Pradaxa intake)
- Percentage of Patients With Major Extra-surgical Site Bleedings During Total Treatment Period(From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed)
- Volume of Wound Drainage (Post-operative)(From end of surgery (before first dosing) until 24 hours after last Pradaxa intake)
- Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period(From first enoxaparin administration until 24 hours after last Pradaxa intake ( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery))