Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery

Summary

The hypothesis of this study is that the antifibrinolytic drugs aprotinin and tranexamic acid equally influence bleeding tendency and transfusion requirement in patients undergoing first time cardiac procedures with a low risk of increased postoperative bleeding.Only patients undergoing first time CABG or first time aortic valve replacement are included in this study.

Timeline

Start

2005-01

Primary completion

—

Completion

2006-07

Outcome

Mixed primary results

paper In the aprotinin Group 47% of patients received allogeneic blood during the hospital stay as compared to 61% in the tranexamic acid group (P = 0.036). PMID 18931201 ↗

paper Overall, no significant difference in postoperative bleeding was observed PMID 18931201 ↗

Publications

• Background Diprose P, Herbertson MJ, O'Shaughnessy D, Deakin CD, Gill RS. Reducing allogeneic transfusion in cardiac surgery: a randomized double-blind placebo-controlled trial of antifibrinolytic therapies used in addition to intra-operative cell salvage. Br J Anaesth. 2005 Mar;94(3):271-8. doi: 10.1093/bja/aei044. Epub 2004 Dec 10.
• Background Henry DA, Moxey AJ, Carless PA, O'Connell D, McClelland B, Henderson KM, Sly K, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2001;(1):CD001886. doi: 10.1002/14651858.CD001886.
• Background Royston D, Levy JH, Fitch J, Dietrich W, Body SC, Murkin JM, Spiess BD, Nadel A. Full-dose aprotinin use in coronary artery bypass graft surgery: an analysis of perioperative pharmacotherapy and patient outcomes. Anesth Analg. 2006 Nov;103(5):1082-8. doi: 10.1213/01.ane.0000238447.74029.f5.
• Background Dietrich W, Busley R, Kriner M. High-dose aprotinin in cardiac surgery: is high-dose high enough? An analysis of 8281 cardiac surgical patients treated with aprotinin. Anesth Analg. 2006 Nov;103(5):1074-81. doi: 10.1213/01.ane.0000238446.30034.c8.
• Lison S, Dietrich W, Braun S, Boehm J, Schuster T, Englhard A, Perchuc A, Spannagl M, Busley R. Enhanced thrombin generation after cardiopulmonary bypass surgery. Anesth Analg. 2011 Jan;112(1):37-45. doi: 10.1213/ANE.0b013e3181fc6df0. Epub 2010 Dec 2.
• Dietrich W, Spannagl M, Boehm J, Hauner K, Braun S, Schuster T, Busley R. Tranexamic acid and aprotinin in primary cardiac operations: an analysis of 220 cardiac surgical patients treated with tranexamic acid or aprotinin. Anesth Analg. 2008 Nov;107(5):1469-78. doi: 10.1213/ane.0b013e318182252b.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aprotinin	Unknown	5e+06 iu	—
Subject	Tranexamic Acid	Small molecule	6 g	—

Indications