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

Bayer

Overview

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

Study Type

OBSERVATIONAL

Conditions

Prophylaxis, Thromboembolism, Venous Total Knee Replacement Total Hip Replacement

Interventions

Rivaroxaban (Xarelto, BAY59-7939)DRUG

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: * Exclusion criteria must be read in conjunction with the local product information * Patients on UFH / LMWH therapy, fondaparinux and vitamin K antagonists are not eligible. * Patients with history of hypersensitivity to active ingredients or excipient :cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Outcomes

Primary Outcomes

Safety related variables are bleeding events reported as major or non-major adverse events

Time frame: 3 months after the day of surgery

Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events

Time frame: 3 months after the day of surgery

All cause mortality

Time frame: 3 months after the day of surgery

Data from ClinicalTrials.gov

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