Rivaroxaban in Endovenous Laser Ablation With and Without Miniphlebectomy

Bleeding Clinical Trial

— RITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584842
• Other study ID #: EKNZ 2014-346
• Status: Completed
• Phase: N/A
• First received: May 21, 2015
• Last updated: October 22, 2015
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bleeding
• Thromboembolism
• Thrombosis
• Varicose Veins
• Venous Thrombosis

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of major or clinically relevant bleedings within 6 weeks after endovenous laser ablation.		within 6 weeks after endovenous laser ablation	Yes