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Aprotinin in Neonates Undergoing Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT00469742
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : March 16, 2012
Information provided by:

Study Description
Brief Summary:
This is a retrospective chart review study. The purpose of this study is to review our experience at Children's Healthcare of Atlanta in neonates receiving aprotinin. We will examine the specific outcomes of renal dysfunction, thrombosis and mortality.

Condition or disease
Cardiopulmonary Bypass Congenital Defects Hemostasis

Detailed Description:

Aprotinin (Trasylol; Bayer Corporation, Pittsburgh, PA), a serine protease inhibitor isolated from bovine lung, is used intra-operatively during cardiac surgery to reduce bleeding. It is thought to work by inhibiting the contact activation phase of the coagulation cascade, reducing thrombin generation, preventing fibrinolysis and attenuating cardiopulmonary bypass (CPB)-induced platelet dysfunction.Though the efficacy of aprotinin in reducing blood loss in adults undergoing CPB is well established, its safety profile, specifically its association with renal dysfunction, thrombosis and long-term mortality, has been questioned. Although the homeostatic derangements of CPB are more significant in pediatric patients, its efficacy and safety profiles in this patient population are actually less clear. In children undergoing re-operative cardiac surgical procedures, aprotinin has been shown to be effective in attenuating post-bypass coagulopathies and decreasing blood product exposure (4). However, little information is available for neonates undergoing CPB who receive intra-operative aprotinin especially in terms of renal dysfunction and thrombosis.

All neonates who underwent Cardiopulmonary Bypass surgery (CPB) at Children's Healthcare of Atlanta between March 1, 2004 and March 1, 2007 will be candidates for this retrospective chart review. Notations will be made regarding those who received aprotinin and those who did not. Primary end points will include post-operative renal dysfunction, need for temporary dialysis, thrombosis and in-hospital mortality. Post -operative renal dysfunction will be defined as a doubling of the pre-operative creatinine level within the first 72 hours after surgery. Thrombosis found during the initial hospitalization will be considered significant. Chart review will gather demographic data (age, weight and type of surgery) as well as other data including CPB time, aortic cross clamp time, presence of regional perfusion, lowest temperature on CPB, time to chest closure, hours with a NIRS value below 40 in the first 24 hours post-op, highest recorded lactate value, blood products administered in the first 24 hours post-op, chest tube drainage in the first 24 hours post-op, first post-op weight, time to extubation and time to ICU discharge.

Study Design

Study Type : Observational
Estimated Enrollment : 290 participants
Time Perspective: Retrospective
Official Title: Safety Profile of Aprotinin in Neonates Undergoing Cardiopulmonary Bypass: A Retrospective Chart Review
Study Start Date : April 2007
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Aprotinin
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
neonates who underwent Cardiopulmonary Bypass (CPB) at Chldren's Healthcare of Atlanta between March 2004 and March 2007.

Inclusion Criteria:

  • Neonates who underwent Cardiopulmonary Bypass (CPB) at Children's Healthcare of Atlanta between March 2004 and March 2007.

Exclusion Criteria:

  • All candidates who do not meet inclusion criteria.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469742

United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Principal Investigator: Nina Guzzetta, MD Emory University
More Information

Responsible Party: Angela Carrico, Mgr., Children's Healthcare of Atlanta Institutional Review Board
ClinicalTrials.gov Identifier: NCT00469742     History of Changes
Other Study ID Numbers: 07-020
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: May 2010

Keywords provided by Children's Healthcare of Atlanta:
Cardiac Defects
Cardiopulmonary Bypass Surgery
renal dysfunction

Additional relevant MeSH terms:
Congenital Abnormalities
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action