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| ID | Type | Description | Link |
|---|---|---|---|
| version 2 |
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The primary objective of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Eurofarma Laboratory product when compared to porcine heparin APP Pharmaceutical in patients undergoing surgery cardiovascular disease and who require cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on measurements of markers of coagulation ACT, aPTT, anti-Xa heparin levels and the excessive blood loss (hemorrhage) after the end of surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| heparin of bovine origin | Experimental | 5.000UI/mL bottle with 5mL |
|
| heparin of porcine origin | Active Comparator | 5000 USP Heparin Units / mL vial with 10 mL vial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bovine Heparin | Biological | 5.000UI/mL bottle with 5mL |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Coagulometric parameters markers heparin activity: ACT, APTT and Anti - Xa | (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Value of the total dose of heparin used, the activity and adequate reversal with the use of protamine. | (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre Frederico, Dr. | Contact | +551938293822 | alexandre@lalclinica.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAL Clinica Pesquisa e Desenvolvimento Ltda | Recruiting | Valinhos | São Paulo | 13276-245 | Brazil |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Porcine heparin |
| Biological |
5000 USP Heparin Units / mL vial with 10 mL vial |
|