REVIparin-BRIDging-in a General Practice Setting in GErmany

NCT ID: NCT02579122

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 77 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-07-31

Brief Summary

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.

Conditions

Thromboembolism

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Winicker Norimed GmbH

INDUSTRY

Sponsor Role: collaborator

Mylan Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alisia Sachse, MD

Role: STUDY_DIRECTOR

Mylan

Locations

Research Facility 52

Berlin, , Germany

Research facility 49

Berlin, , Germany

Research facility 136

Essen, , Germany

Research facility 139

Gladbeck, , Germany

Research Facility 163

Herne, , Germany

Research facility 123

Krefeld, , Germany

Research Facility 82

Landsberg, , Germany

Research facility 84

Leipzig, , Germany

Research facility 70

Nossen, , Germany

Research facility 119

Wachtendonk, , Germany

Research facility 125

Wachtendonk, , Germany

Countries

Germany

Other Identifiers

DE_2015_REVI_PMOS

Identifier Type: -

Identifier Source: org_study_id