Overview

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

Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Duke University
Collaborators:
Grifols Biologicals Inc.
Grifols Biologicals, LLC
Treatments:
Antithrombin III
Antithrombins
Thrombin