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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARIXTRA infusion | Drug | |||
| Enoxaparine infusion | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Zhengzhou | Henan | 450052 | China | ||
| GSK Investigational Site |
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| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Xi'an |
| Shaanxi |
| 710032 |
| China |
| GSK Investigational Site | Qingdao | Shandong | 266001 | China |
| GSK Investigational Site | Chengdu | Sichuan | 610041 | China |
| GSK Investigational Site | Hangzhou | Zhejiang | 310009 | China |
| GSK Investigational Site | Beijing | 100044 | China |
| GSK Investigational Site | Shanghai | 200025 | China |