Should Aprotinin be reconsidered for use in pediatric surgery?

Paediatric Anaesthesia

Volumn 24, Issue 2, 2014, Pages 137-140

  Goobie, Susan ^a  

^a BOSTON CHILDREN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMINOCAPROIC ACID; APROTININ; TRANEXAMIC ACID; ANTIFIBRINOLYTIC AGENT; HEMOSTATIC AGENT;

ANAPHYLAXIS; BLOOD CONSERVATION; BLOOD TRANSFUSION; CARDIOVASCULAR SURGERY; CORONARY ARTERY BYPASS GRAFT; CRANIOFACIAL SURGERY; HEART SURGERY; HUMAN; MAJOR SURGERY; META ANALYSIS (TOPIC); NEPHROTOXICITY; OPERATIVE BLOOD LOSS; PEDIATRIC SURGERY; POSTOPERATIVE HEMORRHAGE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; REVIEW; SURGICAL PATIENT; SYSTEMATIC REVIEW (TOPIC); BLOOD LOSS, SURGICAL; CHILD; GENERAL SURGERY; PEDIATRICS; UNITED STATES;

ANTIFIBRINOLYTIC AGENTS; APROTININ; BLOOD LOSS, SURGICAL; CHILD; GENERAL SURGERY; HEMOSTATICS; HUMANS; PEDIATRICS; UNITED STATES;

EID: 84891780474     PISSN: 11555645     EISSN: 14609592     Source Type: Journal    
DOI: 10.1111/pan.12312     Document Type: Review

References (32)

1. Levy JH,. Antifibrinolytic therapy: new data and new concepts. Lancet 2010; 376: 3-4.
2. Graham EM, Atz AM, Gillis J, et al,. Differential effects of aprotinin and tranexamic acid on outcomes and cytokine profiles in neonates undergoing cardiac surgery. J Thorac Cardiovasc Surg 2012; 143: 1069-1076.
3. Ishibashi N, Iwata Y, Zurakowski D, et al,. Aprotinin protects the cerebral microcirculation during cardiopulmonary bypass. Perfusion 2009; 24: 99-105.
4. Levy JH,. Overview of clinical efficacy and safety of pharmacologic strategies for blood conservation. Am J Health Syst Pharm 2005; 62 (Suppl 4): S15-S19.
5. U.S. Food and Drug Administration. Information for healthcare professionals: aprotinin injection (marketed as trasylol) 2006. Available at: http://www.accessdata.fda.gov/drugsatfda-docs/label/2006/020304s022lbl.pdf. Accesssed 20 November, 2013.
6. Haas S,. Aprotinin-A Blood-Saving Substance. Infus Ther Transfus Med 2002; 29: 151-155.
7. Mangano DT, Tudor IC, Dietzel C,. The risk associated with aprotinin in cardiac surgery. N Engl J Med 2006; 354: 353-365.
8. Karkouti K, Beattie WS, Dattilo KM, et al,. A propensity score case-control comparison of aprotinin and tranexamic acid in high-transfusion- risk cardiac surgery. Transfusion 2006; 46: 327-338.
9. Mangano DT, Miao Y, Vuylsteke A, et al,. Mortality associated with aprotinin during 5 years following coronary artery bypass graft surgery. JAMA 2007; 297: 471-479.
10. Trasylolw (aprotinin injection) briefing document 2007. Available at: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007&4316b1&03-BAYER. pdf Accesssed 01 September, 2013.
11. Fergusson DA, Hebert PC, Mazer CD, et al,. A comparison of aprotinin and lysine analogues in high-risk cardiac surgery. N Engl J Med 2008; 358: 2319-2331.
12. McMullan V, Alston RP III,. Aprotinin and cardiac surgery: a sorry tale of evidence misused. Br J Anaesth 2013; 110: 675-678.
13. Health Canada.Final report-expert advisory panel on Trasylol (aprotinin) 2011. Available at: http://hc-sc.gc.ca/dhp-mps/medeff/advise-consult/eap-gce- trasylol/final-rep-rap-eng.php. Accesssed 20 November, 2013.
14. European Medicines Agency. European Medicines Agency recommends lifting suspension of aprotinin. 2012. Available at: http://www.ema.europa.eu/docs/en- GB/document-library/Press-release/2012/02/WC500122914.pdf. Accesssed 20 November, 2013.
15. Howell N, Senanayake E, Freemantle N, et al,. Putting the record straight on aprotinin as safe and effective: results from a mixed treatment meta-analysis of trials of aprotinin. J Thorac Cardiovasc Surg 2013; 145: 234-240.
16. Eaton MP,. Antifibrinolytic therapy in surgery for congenital heart disease. Anesth Analg 2008; 106: 1087-1100.
17. Basta MN, Stricker PA, Taylor JA,. A systematic review of the use of antifibrinolytic agents in pediatric surgery and implications for craniofacial use. Pediatr Surg Int 2012; 28: 1059-1069.
18. Wilder NS, Kavarana MN, Voepel-Lewis T, et al,. Efficacy and safety of aprotinin in neonatal congenital heart operations. Ann Thorac Surg 2011; 92: 958-963.
19. Pasquali SK, Hall M, Li JS, et al,. Safety of aprotinin in congenital heart operations: results from a large multicenter database. Ann Thorac Surg 2010; 90: 14-21.
20. Pasquali SK, Li JS, He X, et al,. Comparative analysis of antifibrinolytic medications in pediatric heart surgery. J Thorac Cardiovasc Surg 2012; 143: 550-557.
21. D'Errico CC, Munro HM, Buchman SR, et al,. Efficacy of aprotinin in children undergoing craniofacial surgery. J Neurosurg 2003; 99: 287-290.
22. Hutton B, Joseph L, Fergusson D, et al,. Risks of harms using antifibrinolytics in cardiac surgery: systematic review and network meta-analysis of randomised and observational studies. BMJ 2012; 345: e5798.
23. Pharmacia and Upjohn Co. DoP, Cyklokapron Drug Description. FDA package insert. Available at: http://medlibrary.org/lib/rx/meds/cyklokapron-1/. Accesssed 20 November, 2013.
24. American Regent, Inc., Amniocaproic Acid Drug Description. FDA package insert. Available at: http://medlibrary.org/lib/rx/meds/aminocaproic-acid-1/. Accesssed 20 November, 2013.
25. Winter SS, Chaffee S, Kahler SG, et al,. Epsilon-Aminocaproic acid-associated myopathy in a child. J Pediatr Hematol Oncol 1995; 17: 53-55.
26. Breuer T, Martin K, Wilhelm M, et al,. The blood sparing effect and the safety of aprotinin compared to tranexamic acid in paediatric cardiac surgery. Eur J Cardiothorac Surg 2009; 35: 167-171; author reply 71.
27. Murkin JM, Falter F, Granton J, et al,. High-dose tranexamic Acid is associated with nonischemic clinical seizures in cardiac surgical patients. Anesth Analg 2010; 110: 350-353.
28. Kalavrouziotis D, Voisine P, Mohammadi S, et al,. High-dose tranexamic acid is an independent predictor of early seizure after cardiopulmonary bypass. Ann Thorac Surg 2012; 93: 148-154.
29. Lecker I, Wang DS, Romaschin AD, et al,. Tranexamic acid concentrations associated with human seizures inhibit glycine receptors. J Clin Investig 2012; 122: 4654-4666.
30. Martin K, Knorr J, Breuer T, et al,. Seizures after open heart surgery: comparison of epsilon-aminocaproic acid and tranexamic acid. J Cardiothorac Vasc Anesth 2011; 25: 20-25.
31. Martin K, Gertler R, Liermann H, et al,. Switch from aprotinin to epsilon-aminocaproic acid: impact on blood loss, transfusion, and clinical outcome in neonates undergoing cardiac surgery. Br J Anaesth 2011; 107: 934-939.
32. Martin K, Gertler R, MacGuill M, et al,. Replacement of aprotinin by epsilon-aminocaproic acid in infants undergoing cardiac surgery: consequences for blood loss and outcome. Br J Anaesth 2013; 110: 615-621.