ARIXTRA Local Study For Registration In China.
Thromboembolism, Knee Replacement, Hip Replacement
About this trial
This is an interventional prevention trial for Thromboembolism focused on measuring ARIXTRA, prevention of DVT
Eligibility Criteria
Inclusion criteria: Patients undergoing either an elective major hip or knee replacement or revision. Signed written informed consent. Men or women of non-child bearing potential(i.e., post menopausal or with hysterectomy of bilateral tubule ligation) or women of childbearing potential without any plan to have a child. Exclusion criteria: History of serious active bleeding in last 3 month Concurrent or history of thrombocytopenia ( Platelet< 100x109/L) History of hypersensitivity reaction to heparin, Low molecular weight heparin or pork product Acute bacterial endocarditis Congenital or acquired bleeding disease in last 3 months Concurrent uncontrolled ulcer or gastrointestinal disease with blood vessel dysplasia Concurrent hemorrhagic cerebrovascular disease or surgical history in cerebral, spine or eye Conditions need to leave a tubule in intradural or extradural Contraindication to anticoagulant or condition required to take long term oral anticoagulant Abnormality in hepatic (>1.5x UNL), renal (Clcr < 30ml/min) or cardiac function, uncontrolled hypertension or tumor Concurrent disorder of blood vessel in lower limb Positive result in Human Chorionic Gonadotropin test Participated in any other investigational study on Deep Vein Thrombosis prevention in last 90 days. Concurrently to have hip and knee or double hip/knee replacement at the same time
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site