Antithrombin III in Infants With Cardiopulmonary Bypass (CPB)

• Status: Terminated
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Antithrombin III; Antithrombins

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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