Rivaroxaban in Endovenous Laser Ablation With and Without Miniphlebectomy

Rivaroxaban for Thrombosis Prophylaxis in Endovenous Laser Ablation With and Without Miniphlebectomy: A Multicenter Experience

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02584842

Acronym

RITE

Enrollment

400

Registered

2015-10-23

Start date

2012-01-31

Completion date

2014-12-31

Last updated

2015-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding, Thromboembolism, Varicose Veins, Venous Thrombosis

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Number of patients with a EHIT class 3 or class 4 within 6 weeks after endovenous laser ablation	within 6 weeks after endovenous laser ablation

Secondary

Measure	Time frame
Number of major or clinically relevant bleedings within 6 weeks after endovenous laser ablation.	within 6 weeks after endovenous laser ablation

Countries

Switzerland

Outcome results