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| ID | Type | Description | Link |
|---|---|---|---|
| Version 01 - AMENDMENT 01 | |||
| JAN. 2010 |
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The aim of this study is to verify, through clinical examination and doppler, the non-inferiority of the drug test (heparin sodium 5.000UI/0.25 mL - HIPOLABOR) in relation to the drug compared (heparin sodium 5.000USP/mL - APP) in preventing the development of venous thromboembolism (VTE) in patients undergoing surgery for medium risk for the development of this pathology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Hipolabor |
|
| Comparator | Active Comparator | 5.000 USP/mL - APP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heparin sodium - Hipolabor | Biological | 5.000 UI/0,25mL |
| |
| Heparin sodium - APP |
| Measure | Description | Time Frame |
|---|---|---|
| Non-appearance of venous thromboembolism | 2 h before the start of surgery, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lal Clinica Pesquisa E Desenvolvimento Ltda | Valinhos | São Paulo | 13270000 | Brazil |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Biological |
5.000 USP/mL |
|