Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)

Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery or Hip or Knee in Indian Patients

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01523418

Acronym

XYRIS

Enrollment

Registered

2012-02-01

Start date

2014-10-31

Completion date

2016-11-30

Last updated

2016-02-04

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

Conditions

Prophylaxis, Thromboembolism, Venous, Total Hip Replacement, Total Knee Replacement

Keywords

Xarelto, Thromboembolism, Venous, Orthopedic surgery, Factor Xa inhibitor, Observational study

Brief summary

The primary objective of this study is to evaluate the safety of Xarelto in the prophylaxis of VTE in Indian patients undergoing elective TKR/THR

Interventions

DRUGRivaroxaban (Xarelto, BAY59-7939)

The treatment with Xarelto 10mg tablets should comply with the recommendations. Rivaroxaban 10mg OD, 6-10 hours post-op, provided hemostasis has been achieved, for a period of 2 weeks (TKR) & 5 weeks (THR)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients of either sex, undergoing elective THR/TKR, in whom, Rivaroxaban is given for thromboprophylaxis * Patients willing to give a written informed consent

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Safety related variables are bleeding events reported as major or non-major adverse events	3 months after the day of surgery
Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events	3 months after the day of surgery
All cause mortality	3 months after the day of surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026