Trials / Unknown
UnknownNCT01072955
Efficacy And Safety Of Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- Sponsor
- Azidus Brasil · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Bovine Heparin | 5.000UI/mL bottle with 5mL |
| BIOLOGICAL | Porcine heparin | 5000 USP Heparin Units / mL vial with 10 mL vial |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2010-08-01
- Completion
- 2011-10-01
- First posted
- 2010-02-22
- Last updated
- 2011-01-28
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01072955. Inclusion in this directory is not an endorsement.