Aprotinin in Neonates Undergoing Cardiopulmonary Bypass

NCT00469742 | Completed

• 1 other identifier: 07-020
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiopulmonary Bypass; Congenital Defects; Hemostasis

Keywords

Cardiology; Pediatrics; Cardiac Defects; Cardiopulmonary Bypass Surgery; Aprotinin; thrombosis; renal dysfunction

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Children's Healthcare of Atlanta: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Related Publications (4)

• Dietrich W, Spath P, Zuhlsdorf M, Dalichau H, Kirchhoff PG, Kuppe H, Preiss DU, Mayer G. Anaphylactic reactions to aprotinin reexposure in cardiac surgery: relation to antiaprotinin immunoglobulin G and E antibodies. Anesthesiology. 2001 Jul;95(1):64-71; discussion 5A-6A. doi: 10.1097/00000542-200107000-00015.

  PMID: 11465586 BACKGROUND

• Arnold DM, Fergusson DA, Chan AK, Cook RJ, Fraser GA, Lim W, Blajchman MA, Cook DJ. Avoiding transfusions in children undergoing cardiac surgery: a meta-analysis of randomized trials of aprotinin. Anesth Analg. 2006 Mar;102(3):731-7. doi: 10.1213/01.ane.0000194954.64293.61.

  PMID: 16492820 BACKGROUND

• Mangano DT, Miao Y, Vuylsteke A, Tudor IC, Juneja R, Filipescu D, Hoeft A, Fontes ML, Hillel Z, Ott E, Titov T, Dietzel C, Levin J; Investigators of The Multicenter Study of Perioperative Ischemia Research Group; Ischemia Research and Education Foundation. Mortality associated with aprotinin during 5 years following coronary artery bypass graft surgery. JAMA. 2007 Feb 7;297(5):471-9. doi: 10.1001/jama.297.5.471.

  PMID: 17284697 BACKGROUND

• Miller BE, Tosone SR, Tam VK, Kanter KR, Guzzetta NA, Bailey JM, Levy JH. Hematologic and economic impact of aprotinin in reoperative pediatric cardiac operations. Ann Thorac Surg. 1998 Aug;66(2):535-40; discussion 541. doi: 10.1016/s0003-4975(98)00469-x.

  PMID: 9725399 BACKGROUND

MeSH Terms

Conditions

Congenital Abnormalities; Thrombosis; Renal Insufficiency

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Nina Guzzetta, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2007
• First Posted: May 4, 2007
• Study Start: April 1, 2007
• Study Completion: December 1, 2008
• Last Updated: March 16, 2012

Record last verified: 2010-05

Locations

US (1)