REVIparin-BRIDging-in a General Practice Setting in GErmany (REVIBRIDGE)

Mylan

Status: Terminated

Conditions: Thromboembolism

Study type: Observational

Funder types: Industry

Identifiers

NCT02579122

DE_2015_REVI_PMOS

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Children
• 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)