Cardiopulmonary Bypass Clinical Trial
Official title:
Antithrombin Enhancement May Improve Anticoagulation Efficiency in Infants Undergoing Cardiopulmonary Bypass for Cardiac Surgery
The primary objective of this study is:
1. To evaluate the use of Antithrombin (AT) concentrate in infants less than one year of age
undergoing cardiopulmonary bypass (CPB) for cardiac surgery
The secondary objectives of this study are:
1. To determine if the administration of AT concentrate prior to heparinization will
decrease the amount of heparin required to achieve optimal anticoagulation (as defined
by anti-Xa levels) during CPB
2. To determine if a decrease in activation and consumption of coagulation proteins,
platelets and subsequent fibrinolysis will result in improved haemostasis following CPB
3. To determine if there will be a reduction in postoperative bleeding and associated
clinical complications
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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