Antithrombin III Supplementation for Cardiopulmonary Bypass in Neonates

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Postoperative Hemorrhage

In brief

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.

Key facts

Study ID

NCT01158729

Run by

Medical College of Wisconsin

People needed

8

Starts

2011-08-01

Expected to finish

2013-12-01

Last updated by the study team

2014-01-20

Who can join

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

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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