NCT01530737

Antithrombin Enhancement May Improve Anticoagulation Efficiency in Infants Undergoing Cardiopulmonary Bypass for Cardiac Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 364 Days
• Healthy volunteers: Not accepted

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

Conditions

• Cardiopulmonary Bypass

Interventions

Type	Name	Description
DRUG	Antithrombin III	Patients randomized to receive Antithrombin concentrate will receive a dose of AT to achieve a target value of 1.2U/ml.
OTHER	Saline Placebo	Patients randomized to the control group will receive a placebo consisting of normal saline in a volume equivalent to the volume of antithrombin the same patient in the treatment group would have received and administered by anesthesia and perfusion in the exact same manner as the AT is administered in the treatment group.

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2012-02-10
• Last updated: 2015-01-07

Locations

1 site across 1 country: Canada