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Completed

NCT Number: NCT02584842

Rivaroxaban in Endovenous Laser Ablation With and Without Miniphlebectomy

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.

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Key information

Conditions

Varicose Veins Bleeding Cardiovascular Diseases Embolism and Thrombosis Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of major or clinically relevant bleedings within 6 weeks after endovenous laser ablation.

    Time frame: within 6 weeks after endovenous laser ablation

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: RITE

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 23, 2015
Registry last updated
Oct 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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