ThromboembolismREVIBRIDGENCT02579122
REVIparin-BRIDging-in a General Practice Setting in GErmany
An observational study of Thromboembolism, run by Mylan Inc. at 11 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thromboembolism
- How many people
- 77 participants
- Where
- 11 sitesGermany
- Study dates
- Oct 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients under oral anticoagulation with phenprocoumon in general practices
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Research Facility 52
Berlin, 12555
Research facility 49
Berlin, 14052
Research facility 136
Essen, 45219
Research facility 139
Gladbeck, 45968
Research Facility 163
Herne, 44649
Research facility 123
Krefeld, 47798
Research Facility 82
Landsberg, 06188
Research facility 84
Leipzig, 04109
Research facility 70
Nossen, 01683
Research facility 119
Wachtendonk, 47669
Research facility 125
Wachtendonk, 47669
About this study
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
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.
- Conditions
- Thromboembolism
- Keywords
- Reviparin, Bridging, Phenprocoumon
- Medical subject headings
- Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH
- Responsible party
- Sponsor
- Investigators
- Alisia Sachse, MD, Study director, Mylan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579122
- Sponsor's protocol ID
- DE_2015_REVI_PMOS
- Acronym
- REVIBRIDGE
- Status last verified
- Aug 2016
- First submitted
- 29 Sep 2015
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02579122
- Acronym / sponsor ID
- REVIBRIDGE / DE_2015_REVI_PMOS
- Conditions
- Thromboembolism
- Keywords
- Reviparin, Bridging, Phenprocoumon
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH
- Study start
- Oct 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients under oral anticoagulation with phenprocoumon in general practices
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients without thromboembolic or bleeding complications in relation to Reviparin dosage
Time frame: 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.
1 secondary outcome
Documentation of the bridging regimen with reviparin used in Germany.
Time frame: 15 months
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alisia Sachse, MD study director
Mylan
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolism, run by Mylan Inc. at 11 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients without thromboembolic or bleeding complications in relation to Reviparin dosage (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.