REVIparin-BRIDging-in a General Practice Setting in GErmany

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2016

Clinical Trial Outcome Measures

Primary Measures

  • Patients without thromboembolic or bleeding complications in relation to Reviparin dosage
    • Time Frame: 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.

Secondary Measures

  • Documentation of the bridging regimen with reviparin used in Germany.
    • Time Frame: 15 months
    • 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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mylan Inc.
  • Collaborator
    • Winicker Norimed GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alisia Sachse, MD, Study Director, Mylan

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