Antithrombin III Supplementation for Cardiopulmonary Bypass in Neonates

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Medical College of Wisconsin
• Collaborators: Children's National Research Institute; Children's Research Institute; rEVO Biologics
• Treatments: Antithrombin III; Antithrombins

Criteria

Inclusion Criteria:

all sequential neonates (4 - 30 days of age) undergoing surgery requiring cardiopulmonary bypass are eligible to be included in the study.

Exclusion Criteria:

• prior operation utilizing cardiopulmonary bypass

• weight less than 2 kilograms

• prematurity less than 37 weeks estimated gestational age

• previously diagnosed pro-thrombotic or hemorrhagic disorder

• known intracranial hemorrhage

• prior ATIII supplementation

• prior therapeutic anticoagulant use

• known hypersensitivity to goat and goat milk proteins.