REVIparin-BRIDging-in a General Practice Setting in GErmany (REVIBRIDGE). Non-interventional Study to Evaluate Reviparin for Prevention of Thrombosis and Thromboembolism in General and Orthopedic Surgery (Here: for Perioperative Bridging of Oral Anticoagulation in Interventional Procedures) in General Practices
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mylan Inc.
- 入组人数
- 77
- 试验地点
- 11
- 主要终点
- Patients without thromboembolic or bleeding complications in relation to Reviparin dosage
研究概览
简要总结
In view of the fact that little is known about the pre- and post-interventional coagulation management of phenprocoumon patients with reviparin at general practices in Germany, an observational study is being initiated to evaluate the effectiveness and tolerability of reviparin in the area of outpatient, general practice-based care in the context of bridging therapy. Patients for whom bridging therapy with low-molecular weight heparin (LMWH) was specified and for whom the LMWH reviparin was chosen for this purpose shall be investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients > 18 years old
- •Requiring prophylaxis/bridging treatment with reviparin, e.g. for the prevention of venous thromboembolism in general and orthopaedic surgery, due to the decision of the treating physician
排除标准
- •Hypersensitivity to reviparin or one of the excipients of Clivarin® or other low-molecular-weight heparin preparations and/or heparin, e.g. confirmed or suspected immune-mediated heparin-induced thrombocytopenia (type 2)
- •Severe renal impairment (creatinine clearance < 30 ml/min)
- •Bleeding: like other anticoagulants, reviparin should not be used in conditions associated with an increased risk of bleeding, e.g. acute bleeding, haemorrhagic diathesis, coagulation factor deficiencies, severe thrombocytopenia, untreated arterial hypertension, bacterial endocarditis and subacute endocarditis, acute-onset gastrointestinal ulcers or haemorrhages, brain haemorrhage, spinal or ear or eye surgery, intraocular bleeding or corresponding injuries within the past 6 months
- •Severe hepatic or pancreatic impairment
- •Patients with a body weight < 45kg
- •Life expectancy of less than 3 months
- •Pregnant women (due to the generally very long duration of treatment with LMWH in female patients who are already on anticoagulation therapy)
结局指标
主要结局
Patients without thromboembolic or bleeding complications in relation to Reviparin dosage
时间窗: 15 months
Documentation of the effect and the dosage of reviparin for the prevention of thromboembolic events in patients on oral anticoagulation (OAC) with phenprocoumon who need to undergo an elective surgical procedure or invasive investigation (target International Normalized Ratio (INR) between 2 and 3) and therefore receive bridging anticoagulation.
次要结局
- Documentation of the bridging regimen with reviparin used in Germany.(15 months)