Clinical trial NCT02579122: REVIparin-BRIDging-in a General Practice Setting in GErmany
Official title: 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: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Thromboembolism
Keywords: Reviparin
Bridging
Phenprocoumon
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Winicker Norimed GmbH
First posted: 2015-10-19
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients under oral anticoagulation with phenprocoumon in general practices

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.


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)

Primary outcomes:
measure: Patients without thromboembolic or bleeding complications in relation to Reviparin dosage
timeFrame: 15 months
Secondary outcomes:
measure: Documentation of the bridging regimen with reviparin used in Germany.
timeFrame: 15 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Facility 52
city: Berlin
country: Germany
facility: Research facility 49
city: Essen
country: Germany
facility: Research facility 136
city: Gladbeck
country: Germany
facility: Research facility 139
city: Herne
country: Germany
facility: Research Facility 163
city: Krefeld
country: Germany
facility: Research facility 123
city: Landsberg
country: Germany
facility: Research Facility 82
city: Leipzig
country: Germany
facility: Research facility 84
city: Nossen
country: Germany
facility: Research facility 70
city: Wachtendonk
country: Germany
facility: Research facility 119
city: Wachtendonk
country: Germany
facility: Research facility 125
Study officials:
affiliation: Mylan
name: Alisia Sachse, MD
role: STUDY_DIRECTOR
References: