drugset / Trial / NCT01530737
Antithrombin Enhancement May Improve Anticoagulation Efficiency in Infants Undergoing Cardiopulmonary Bypass for Cardiac Surgery
RandomizedParallel-groupDouble-blindTreatment
Summary
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
Timeline
- Start
- 2011-11
- Primary completion
- 2014-10
- Completion
- 2014-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Antithrombin III | Protein / enzyme biologic | — | — |
Indications
No indication recorded.