ARIXTRA Local Study For Registration In China.

Study Overview
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Brief Summary
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This is a local registration study in China to compare the safety and efficacy of ARIXTRA to Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of components.

Official Title
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Randomized, Single Blind, Parallel Study to Compare the Safety and Efficacy of ARIXTRA to Enoxaparine in Patients Undergoing Elective Major Hip or Knee Replacement or a Revision of Components.

Conditions
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Thromboembolism, Knee Replacement, Hip Replacement

Intervention / Treatment
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* Drug: ARIXTRA infusion
* Drug: Enoxaparine infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ARIXTRA infusion|nan|
|Drug: Enoxaparine infusion|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARIXTRA, prevention of DVT