Status:
TERMINATED
Antithrombin III Supplementation for Cardiopulmonary Bypass in Neonates
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
Children's National Research Institute
rEVO Biologics
Conditions:
Postoperative Hemorrhage
Eligibility:
All Genders
4-30 years
Phase:
PHASE1
Brief Summary
A prospective, randomized, placebo-controlled, double-blinded pilot study is planned. Neonates undergoing surgeries requiring cardiopulmonary bypass will receive antithrombin III (ATIII) supplementati...
Detailed Description
Hypothesis: ATIII supplementation prior to initiation of cardiopulmonary bypass (CPB) to neonates will be safe and result in less postoperative bleeding and transfusion of packed red blood cells (pRB...
Eligibility Criteria
Inclusion
- all sequential neonates (4 - 30 days of age) undergoing surgery requiring cardiopulmonary bypass are eligible to be included in the study.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01158729
Start Date
August 1 2011
End Date
December 1 2013
Last Update
January 20 2014
Active Locations (1)
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1
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226