Total Knee Replacement Clinical Trial
— XYRISOfficial title:
Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery or Hip or Knee in Indian Patients
Verified date | February 2016 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Drugs Controller General of India |
Study type | Observational |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety related variables are bleeding events reported as major or non-major adverse events | 3 months after the day of surgery | Yes | |
Primary | Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events | 3 months after the day of surgery | Yes | |
Primary | All cause mortality | 3 months after the day of surgery | Yes |
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