REVIparin-BRIDging-in a General Practice Setting in GErmany

Terminated

• Conditions: Thromboembolism

• Registration Number: NCT02579122
• Lead Sponsor: Mylan Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-29
• Study Start: 2015-10
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 77

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients without thromboembolic or bleeding complications in relation to Reviparin dosage	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 Outcome Measures

Name	Time	Method
Documentation of the bridging regimen with reviparin used in Germany.	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

Trial Locations

Locations (11)

Research facility 136; 🇩🇪 Essen, Germany

Research facility 139; 🇩🇪 Gladbeck, Germany

Research facility 70; 🇩🇪 Nossen, Germany

Research Facility 163; 🇩🇪 Herne, Germany

Research facility 49; 🇩🇪 Berlin, Germany

Research Facility 52; 🇩🇪 Berlin, Germany

Research facility 123; 🇩🇪 Krefeld, Germany

Research Facility 82; 🇩🇪 Landsberg, Germany

Research facility 84; 🇩🇪 Leipzig, Germany

Research facility 119; 🇩🇪 Wachtendonk, Germany

Research facility 125; 🇩🇪 Wachtendonk, Germany