Varicose VeinsRITENCT02584842
Rivaroxaban in Endovenous Laser Ablation With and Without Miniphlebectomy
An observational study of Varicose Veins and Venous Thrombosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine retrospectively if the application of rivaroxaban after endovenous laser ablation with and without miniphlebectomy is safe and if it lowers the risk of venous thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins, Venous Thrombosis, Thromboembolism
- How many people
- 400 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Dec 2014
- 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 age greater than 18 years, informed consent was given. EVLA of the GSV, ASV and/or SSV using 1470 nm wavelength radial laser (ELVeS, Biolitec, Austria) and postinterventional EHIT prophylaxis with rivaroxaban.
Who may be able to join
- Patients age greater than 18 years, informed consent was given.
- Endovenous Laser Ablation (EVLA) of the greater saphenous vein (GSV), autologous saphenous vein (ASV) and/or small saphenous vein (SSV) using 1470 nm wavelength radial laser (ELVeS, Biolitec, Austria) and postinterventional Endothermal Heat Induced Thrombosis (EHIT) prophylaxis with rivaroxaban.
Who cannot join
- Patients are ineligible if they had:
- an endovenous ablation technique other than EVLA,
- other veins than GSV, ASV or SSV treated with EVLA (i.e. perforators),
- postinterventional EHIT prophylaxis other than prophylactic dose of rivaroxaban or
- informed consent was not given.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Rivaroxaban for Thrombosis Prophylaxis in Endovenous Laser Ablation With and Without Miniphlebectomy: A Multicenter Experience
The purpose of this study is to determine retrospectively if the application of rivaroxaban after endovenous laser ablation with and without miniphlebectomy is safe and if it lowers the risk of venous thrombosis.
Read the detailed description
Rivaroxaban is an orally active direct factor Xa inhibitor, that is used for thrombosis prophylaxis for example in the setting of orthopaedic surgery.
In the observed situation Rivaroxaban was applied in a dosage of 10mg daily during 5 days after endovenous laser ablation.
- Conditions
- Varicose Veins, Venous Thrombosis, Thromboembolism, Bleeding
- Medical subject headings
- Varicose Veins, Venous Thrombosis, Thromboembolism, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a EHIT class 3 or class 4 within 6 weeks after endovenous laser ablation
Measured: within 6 weeks after endovenous laser ablation
Secondary outcomes (1)
Number of major or clinically relevant bleedings within 6 weeks after endovenous laser ablation.
Measured: within 6 weeks after endovenous laser ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Spinedi, MD, Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584842
- Sponsor's protocol ID
- EKNZ 2014-346
- Acronym
- RITE
- Status last verified
- Oct 2015
- First submitted
- 21 May 2015
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Uthoff H, Holtz D, Broz P, Staub D, Spinedi L. Rivaroxaban for thrombosis prophylaxis in endovenous laser ablation with and without phlebectomy. J Vasc Surg Venous Lymphat Disord. 2017 Jul;5(4):515-523. doi: 10.1016/j.jvsv.2016.12.002. Epub 2017 Feb 21.
PubMed 28623988
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban for Thrombosis Prophylaxis in Endovenous Laser Ablation With and Without Miniphlebectomy: A Multicenter Experience
- ClinicalTrials.gov ID
- NCT02584842
- Acronym / sponsor ID
- RITE / EKNZ 2014-346
- Conditions
- Varicose Veins, Venous Thrombosis, Thromboembolism, Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 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.
The purpose of this study is to determine retrospectively if the application of rivaroxaban after endovenous laser ablation with and without miniphlebectomy is safe and if it lowers the risk of venous thrombosis.
Detailed description
Rivaroxaban is an orally active direct factor Xa inhibitor, that is used for thrombosis prophylaxis for example in the setting of orthopaedic surgery.
In the observed situation Rivaroxaban was applied in a dosage of 10mg daily during 5 days after endovenous laser ablation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients age greater than 18 years, informed consent was given. EVLA of the GSV, ASV and/or SSV using 1470 nm wavelength radial laser (ELVeS, Biolitec, Austria) and postinterventional EHIT prophylaxis with rivaroxaban.
Key inclusion criteria (2 listed)
- Patients age greater than 18 years, informed consent was given.
- Endovenous Laser Ablation (EVLA) of the greater saphenous vein (GSV), autologous saphenous vein (ASV) and/or small saphenous vein (SSV) using 1470 nm wavelength radial laser (ELVeS, Biolitec, Austria) and postinterventional Endothermal Heat Induced Thrombosis (EHIT) prophylaxis with rivaroxaban.
Key exclusion criteria (5 listed)
- an endovenous ablation technique other than EVLA,
- other veins than GSV, ASV or SSV treated with EVLA (i.e. perforators),
- postinterventional EHIT prophylaxis other than prophylactic dose of rivaroxaban or
- informed consent was not given.
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
Number of patients with a EHIT class 3 or class 4 within 6 weeks after endovenous laser ablation
Time frame: within 6 weeks after endovenous laser ablation
1 secondary outcome
Number of major or clinically relevant bleedings within 6 weeks after endovenous laser ablation.
Time frame: within 6 weeks after endovenous laser ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
- Derived from this study: PubMed 28623988Uthoff H, Holtz D, Broz P, Staub D, Spinedi L. Rivaroxaban for thrombosis prophylaxis in endovenous laser ablation with and without phlebectomy. J Vasc Surg Venous Lymphat Disord. 2017 Jul;5(4):515-523. doi: 10.1016/j.jvsv.2016.12.002. Epub 2017 Feb 21.
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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.
Luca Spinedi, MD, Dr. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins and Venous Thrombosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 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: finished, as of the sponsor's last update on 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with a EHIT class 3 or class 4 within 6 weeks after endovenous laser ablation (time frame: within 6 weeks after endovenous laser ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02584842, which also lists 1 linked publication.
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 23 Oct 2015.