REVIparin-BRIDging-in a General Practice Setting in GErmany

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Thromboembolism

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients without thromboembolic or bleeding complications in relation to Reviparin dosage | 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. | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of the bridging regimen with reviparin used in Germany. | mean reviparin dose regimen measured in IU anti-Xa/ per day along with preoperative phenprocoumon withdrawal and postoperative re-onset over the related time course | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reviparin, Bridging, Phenprocoumon