Anti-thrombin III (ATIII) vs Placebo in Children (<7mo) Undergoing Open Congenital Cardiac Surgery

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test whether the administration of ATIII during the intra-operative period results in improved anticoagulation for cardiopulmonary bypass (CPB) and an attenuation of the activation of the coagulation cascade, as represented by a decrease in fibrin degradation products. The investigators believe this benefit would extend into the post-operative period resulting in a decreased incidence of thrombosis generation, as represented by a decrease in fibrin degradation products in the ICU period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborators: Grifols Biologicals Inc.; Grifols Biologicals, LLC
• Treatments: Antithrombin III; Antithrombins; Thrombin

Criteria

Inclusion Criteria:

• All patients less than 7 months of age going for cardiac surgery that will require cardiopulmonary bypass (CPB) with a documented ATIII level below 70%

Exclusion Criteria:

• Less than 2.5kg

• Known or suspected hereditary ATIII deficiency (family history of venous thrombosis with decreased plasma levels of ATIII and no other potential causes of acquired decreased ATIII)

• On Ecmo (extracorporeal membrane oxygenation ) at time of surgery

• Known history of thrombosis

• Renal failure as described by the pediatric RIFLE criteria

• H/o intracranial hemorrhage

• Prematurity less than 37 weeks estimated gestational age

• Previously diagnosed pro-thrombotic or hemorrhagic disorder

• Prior ATIII supplementation

• Prior therapeutic anticoagulant use