drugset / Trial / NCT02103114

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

NCT02103114

Phase 2 Completed 45 enrolled Duke University Grifols Biologicals, LLC · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2014-06
Primary completion
2016-06-27
Completion
2016-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Antithrombin III Protein / enzyme biologic