Aprotinin in Neonates Undergoing Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00469742
First received: May 2, 2007
Last updated: March 14, 2012
Last verified: May 2010
  Purpose

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
Cardiopulmonary Bypass
Congenital Defects
Hemostasis

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Safety Profile of Aprotinin in Neonates Undergoing Cardiopulmonary Bypass: A Retrospective Chart Review

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Estimated Enrollment: 290
Study Start Date: April 2007
Study Completion Date: December 2008
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.

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
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.

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00469742

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

Publications:
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
Study First Received: May 2, 2007
Last Updated: March 14, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Congenital Abnormalities
Aprotinin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014