Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux,in Venous Thromboembolic Events Prevention in Patients With Renal Impairment and Undergoing a Major Orthopaedic Surgery. PROPICE Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 451
- 试验地点
- 29
- 主要终点
- Number of Patients With Major Bleedings Between Day 1 and Day 10.
研究概览
简要总结
Fondaparinux is an antithrombotic agent having already received a regulatory approval by the European Authorities in venous thromboembolic event prevention after major orthopaedic surgery, as total hip replacement (THR), total knee replacement (TKR), hip fracture (HF). The bleeding risk associated with this prescription is highly related to renal function evaluated by creatinin clearance (CrCl). In order to reduce the bleeding risk, it has been proposed to prescribe fondaparinux 1.5 mg/day in patients with a CrCl between 20 and 50ml/mn instead of 2.5mg/day (European MMA). In the meantime, this approval is essentially based on simulated pharmakinetic data without any support of clinical data.
prospective, multicentre, open-label study evaluating the safety profile of fondaparinux 1.5 mg/day, subcutaneously administered, in patients with a renal impairment defined by a CrCl between 20 and 30 ml/min and undergoing a major orthopaedic surgery.
详细描述
Fondaparinux 1.5mg/day subcutaneously administered during post-surgery 1 to 10 days with the 1st treatment administration performed 6 to 8 hours after the end of surgery.
Screening visit : > 7 days before inclusion visit if THR and TKR Inclusion visit : day of surgery Visits with blood drawing: 3 visits scheduled during 1 to 10 days of treatment period Study end of treatment visit: D1 to D10 Study end visit: 1 month ± 15 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •• age > 18 years old,
- •undergoing a major orthopaedic surgery (THR, TKR, HF) whatever procedure techniques are used, 1st indication or 2nd indication,
- •requiring an antithrombotic prophylaxis,
- •presenting a renal impairment defined by a creatinin clearance (CrCl) between 20 and 50 ml/min calculated by Cockcroft and Gault's formula,
- •having signed the inform consent form.
排除标准
- •contra-indications to fondaparinux,
- •history of heparin inducted thrombopenia (HIT),
- •platelets < 100 g/l.
研究组 & 干预措施
1
patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
干预措施: fondaparinux 1.5 mg/day (Drug)
结局指标
主要结局
Number of Patients With Major Bleedings Between Day 1 and Day 10.
时间窗: 10 day
evaluate between Day 1 and Day 10, the number of patients under study treatment who has affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of \>2 units of packed red blood cells or was associated with a fall in hemoglobin \>20 g/L.
次要结局
- Number of Patients With Major Bleedings at 1 Month ± 5 Days.(45 day)
- Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10(10 days)
- Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days(at 1 month ± 5)
- Death at 1 Month ± 5 Days(1 month ± 5 days)