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| ID | Type | Description | Link |
|---|---|---|---|
| (Version 8) |
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The objective of this study is to 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 Hipolabor |
|
| 2 | Active Comparator | Heparim Sodium APP 5.000 USP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin sodium Hipolabor | Biological | Heparin sodium Hipolabor 5.000 UI/mL |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of heparin of porcine origin in patients undergoing cardiovascular surgery | Patients undergoing cardiovascular surgery and who require the assistance of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on measurements of coagulation markers ACT, aPTT, anti-Xa heparin serum and excessive blood loss (hemorrhage ) after the final surgery. | 48 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the average dose and and safety of porcine heparin. | Evaluate the mean dose of heparin used in surgery and its relationship to the dose of protamine chloride and the need for blood transfusions and blood products during and after the process | 48 hours after surgery. |
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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 | 13270-000 | Brazil | ||
| LAL Clinica |
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| Heparin sodium APP |
| Biological |
Heparin sodium APP 5.000 USP |
|
| Valinhos |
| São Paulo |
| 13270000 |
| Brazil |