Trials / Completed
CompletedNCT00894998
Efficacy and Safety of Sodium Heparin in Patients (Cristália)
Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- Azidus Brasil · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | heparin sodium - Cristália | Heparin sodium 5000UI - Cristália |
| BIOLOGICAL | Heparin sodium APP | Heparin Sodium 5.000 USP - APP |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2009-09-01
- Completion
- 2011-12-01
- First posted
- 2009-05-07
- Last updated
- 2013-02-25
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT00894998. Inclusion in this directory is not an endorsement.