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TerminatedNCT02579122REVIBRIDGEUpdated Mar 31, 2022

REVIparin-BRIDging-in a General Practice Setting in GErmany

An observational study in Thromboembolism, sponsored by Mylan Inc.. Terminated at 11 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Mylan Inc. · Observational

Why this study was terminated
Poor recruitment
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
77
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Thromboembolism

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Keywords

  • Reviparin
  • Bridging
  • Phenprocoumon
03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's enrollment of 77 is below the median of 500 across 344 observational studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

Mylan Inc. is the lead sponsor of 43 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients under oral anticoagulation with phenprocoumon in general practices

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

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)
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
77 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 15 months

Secondary outcomes

  1. 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

    Time frame: 15 months

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Study locations

11 sites
  • Research Facility 52
    Berlin, 12555, Germany
  • Research facility 49
    Berlin, 14052, Germany
  • Research facility 136
    Essen, 45219, Germany
  • Research facility 139
    Gladbeck, 45968, Germany
  • Research Facility 163
    Herne, 44649, Germany
  • Research facility 123
    Krefeld, 47798, Germany
  • Research Facility 82
    Landsberg, 06188, Germany
  • Research facility 84
    Leipzig, 04109, Germany
  • Research facility 70
    Nossen, 01683, Germany
  • Research facility 119
    Wachtendonk, 47669, Germany
  • Research facility 125
    Wachtendonk, 47669, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02579122
Lead sponsor
Mylan Inc.
Collaborators
Winicker Norimed GmbH
Responsible party
Sponsor
First posted
Oct 19, 2015
Start date
Oct 2015
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Mar 31, 2022

Study contacts

Alisia Sachse, MD
study director · Mylan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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