drugset / Trial / NCT00905216

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

NCT00905216

Phase 3 Unknown 104 enrolled Azidus Brasil
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2009-06
Primary completion
2009-09
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Heparin Other / unclassified 5000 unknown

Indications

No indication recorded.