Rivaroxaban in Endovenous Laser Ablation With and Without... | NCT02584842

Studies
Rivaroxaban in Endovenous Laser Ablation With and Without Miniphlebectomy

NCT02584842

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Oct 23, 2015Estimated

Enrollment

400Actual

Phase

Not provided

Conditions

Varicose Veins
Venous Thrombosis
Thromboembolism
Bleeding

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

May 21, 2015

First Submission Date that Met QC Criteria

Oct 22, 2015

First Posted Date

Oct 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2015

Last Update Posted Date

Oct 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luca Spinedi, MD, Dr.	University Hospital, Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel		Basel	Canton of Basel-City	4031	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28623988	Derived	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.

ID	Term
D014648	Varicose Veins
D020246	Venous Thrombosis
D013923	Thromboembolism
D006470	Hemorrhage

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D013927	Thrombosis
D016769	Embolism and Thrombosis