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| ID | Type | Description | Link |
|---|---|---|---|
| Heparin Blausiegel 1 | |||
| (Version 8) |
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The objective of this study is verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding) at the end of the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Heparin Sodium Blausiegel 1 |
|
| Active Comparator | Experimental | heparin sodium - APP 5.000 USP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin sodium Blausiegel 1 | Biological | Heparin sodium Blausiegel 1 5.000 UI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of TTPA, Anti-Xa and ACT | Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative | |
| Comparison of bleeding | Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions | Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative |
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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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| Heparin sodium APP |
| Biological |
Heparin sodium APP 5.000 USP |
|