NCT02579122

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 31, 2022

Status Verified

August 1, 2016

Enrollment Period

9 months

First QC Date

September 29, 2015

Last Update Submit

March 17, 2022

Conditions

Thromboembolism

Keywords

ReviparinBridgingPhenprocoumon

Outcome Measures

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.

    15 months

Secondary Outcomes (1)

  • Documentation of the bridging regimen with reviparin used in Germany.

    15 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients under oral anticoagulation with phenprocoumon in general practices

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Facility 52

Berlin, 12555, Germany

Location

Research facility 49

Berlin, 14052, Germany

Location

Research facility 136

Essen, 45219, Germany

Location

Research facility 139

Gladbeck, 45968, Germany

Location

Research Facility 163

Herne, 44649, Germany

Location

Research facility 123

Krefeld, 47798, Germany

Location

Research Facility 82

Landsberg, 06188, Germany

Location

Research facility 84

Leipzig, 04109, Germany

Location

Research facility 70

Nossen, 01683, Germany

Location

Research facility 119

Wachtendonk, 47669, Germany

Location

Research facility 125

Wachtendonk, 47669, Germany

Location

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Alisia Sachse, MD

    Mylan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2015

First Posted

October 19, 2015

Study Start

October 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 31, 2022

Record last verified: 2016-08

Locations

DE(11)