Antithrombin III Supplementation for Cardiopulmonary Bypass in Neonates

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2011
A prospective, randomized, placebo-controlled, double-blinded pilot study is planned. Neonates undergoing surgeries requiring cardiopulmonary bypass will receive antithrombin III (ATIII) supplementation or placebo in addition to standard anticoagulation with heparin as currently practiced at Children\'s Hospital of Wisconsin. We plan to enroll the first 60 sequential patients meeting criteria who consent to inclusion. The primary outcomes will be rates of adverse events to monitor safety. Secondary outcomes include volume of postoperative blood loss and packed red blood cell transfusion during the first 24 postoperative hours, and ATIII levels during and after bypass to determine pharmacokinetics.
Epistemonikos ID: efa78b19f10d8ac3c478cde159fd618bb1656ab4
First added on: May 05, 2024