Anti-thrombin III (ATIII) vs Placebo in Children (<7mo) Undergoing Open Congenital Cardiac Surgery
Completed · Phase 2 · Has a placebo group
Conditions studied: ATIII Deficiency
In brief
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.
Key facts
- Study ID
- NCT02103114
- Run by
- Duke University
- People needed
- 45
- Starts
- 2014-06-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2019-11-25
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%
You may not qualify if…
- 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
Where it is running
- Duke University — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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