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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Antithrombin III; Antithrombins

Criteria

Inclusion Criteria:

1. Pediatric patients < 1 year old with cardiac defect (acquired or congenital) requiring cardiac surgery

2. Planned cardiac surgery with cardiopulmonary bypass

3. Weight > 2.5kg at the time of surgery

4. Enrolment in the CATCH main study (REB#1000020203)

Exclusion Criteria:

1. Preoperative antithrombin activity > 85%

2. Prematurity < 36 weeks gestational age at birth

3. Preoperative use of systemic anticoagulant (i.e. heparin or warfarin at a therapeutic dose) for > 24 hours or at any time within the 48 hours prior to surgery

4. Any form of coagulopathy or thrombophilic disorder

5. Renal (blood creatinine - estimated GRF < 60ml/min/1.73m2) or clinical liver failure

6. Antithrombin replacement therapy prior to surgery

7. Repeat surgery (including previous ECMO/VAD support as prior surgery)

8. Patients refusal to provide open consent for re-use of study data