REVIparin-BRIDging-in a General Practice Setting in GErmany

Thromboembolism Clinical Trial

— REVIBRIDGE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02579122
• Other study ID #: DE_2015_REVI_PMOS
• Status: Terminated
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Thromboembolism

Locations

Country	Name	City	State
Germany	Research facility 49	Berlin
Germany	Research Facility 52	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

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	Winicker Norimed GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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