Antithrombin III in Infants With Cardiopulmonary Bypass (CPB)

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Congenital Heart Disease

In brief

The purpose of this study is to discern whether supplementation of Antithrombin III will decrease coagulation and inflammation associated with cardiopulmonary bypass in infants undergoing cardiac surgery.

Key facts

Study ID

NCT01698567

Run by

University of Rochester

People needed

6

Starts

2012-07-01

Expected to finish

2016-03-01

Last updated by the study team

2016-03-22

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects will be included if they are presenting for elective cardiac surgery using cardiopulmonary bypass and are 180 days of age or less.

You may not qualify if…

• Sensitivity to ATIII product (Thrombate, Grifols, Los Angeles, CA)
• Known inherited or acquired coagulation defect
• Current or prior treatment with pro-or anticoagulant medication within past 30 days (except aspirin or a single dose of heparin, e.g. for catheterization)
• Known central venous thrombosis
• Recent (30 days) transfusion with hemostatic blood products (fresh-frozen plasma, platelets, cryoprecipitate, whole blood)
• wt less than 3000g

Where it is running

• Michael Eaton, MD — Rochester, New York, United States

Full record on ClinicalTrials.gov

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