NCT00905216

Efficacy and Safety of Sodium Heparin in Patients Submitted to Heart Surgery Using Bypass

Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using 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 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 that require the aid of cardiopulmonary bypass. The effectiveness will be determined through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation trichloroacetic acid (TCA), alpha-tocopherol transfer protein (TTPA), Anti-Xa, heparin bioavailability and excessive loss of blood (bleeding) at the end of the surgery.

Conditions

• Cardiac Surgery

Interventions

Type	Name	Description
DRUG	heparin sodium - Bergamo	5.000 UI/mL
DRUG	heparin sodium - APP	5.000 USP

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-09-01
• Completion: 2011-12-01
• First posted: 2009-05-20
• Last updated: 2011-01-28

Locations

1 site across 1 country: Brazil