drugset / Trial / NCT01072747

Efficacy And Safety Of Unfractionated Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass

NCT01072747 ↗

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

Summary

The primary objective of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Bergamo Laboratory ACTIPARIN ® 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.

Timeline

Start
2010-04
Primary completion
2011-08
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Bovine Heparin Unknown — —
Comparator Porcine heparin Unknown — —