Rivaroxaban in Endovenous Laser Ablation With and Without Miniphlebectomy

Completed

• Conditions: Varicose Veins; Venous Thrombosis; Thromboembolism; Bleeding

• Registration Number: NCT02584842
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2015-05-21
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-22
• Last Update Submitted: 2015-10-22
• Study First Posted: 2015-10-23
• Last Update Posted: 2015-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Basel Stadt, Switzerland