HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Michel I.M. Versteegh Robert A.E. Dion Robert J.M. Klautz Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Later, A. F.L. Articles by Klautz, R. J.M. Search for Related Content PubMed Articles by Later, A. F.L. Articles by Klautz, R. J.M. Related Collections Anesthesia Cardiac - pharmacology Extracorporeal circulation

Tranexamic acid and aprotinin in low- and intermediate-risk cardiac surgery: a non-sponsored, double-blind, randomised, placebo-controlled trial

^a Department of Cardiothoracic Surgery, Leids Universitair Medisch Centrum, Albinusdreef 2, Postbus 9600, 2300 RC Leiden, The Netherlands
^b Department of Anaesthesiology, LUMC, The Netherlands
^c Department of Intensive Care Medicine, LUMC, The Netherlands
^d Ziekenhuis Oost Limburg, Mosselerlaan 36, B-3600 Genk, Belgium

Received 6 July 2008; received in revised form 1 November 2008; accepted 3 November 2008.

^_* Corresponding author. Address: Department of Cardiothoracic Surgery, Leids Universitair Medisch Centrum, Albinusdreef 2, Postbus 9600, 2300 RC Leiden, The Netherlands. Tel.: +31 71 5264022; fax: +31 71 5266899. (Email: r.j.m.klautz{at}lumc.nl).

Objective: Tranexamic acid has been suggested to be as effective as aprotinin in reducing blood loss and transfusion requirements after cardiac surgery. Previous studies directly comparing both antifibrinolytics focus on high-risk cardiac surgery patients only or suffer from methodological problems. We wanted to compare the effectiveness of tranexamic acid versus aprotinin in reducing postoperative blood loss and transfusion requirements in the patient group representing the majority of cardiac surgery patients: low- and intermediate-risk patients. Methods: We conducted a non-sponsored, double-blind, randomised, placebo-controlled trial in which 298 patients scheduled for low- or intermediate-risk (mean logistic EuroSCORE 4.1) first-time heart surgery with use of cardiopulmonary bypass were randomised to receive either tranexamic acid, high-dose aprotinin, or placebo. All patients had preoperative normal renal function. End points of the study were monitored from the time of surgery until patient discharge. This trial was executed between June 2004 and October 2006. Results: Both antifibrinolytics significantly reduced blood loss and transfusion requirements when compared with placebo. Aprotinin was about twice as effective as tranexamic acid in reducing total postoperative blood loss (estimated median difference 155 ml, 95% confidence interval (CI) 60–260; p < 0.001). Accordingly, aprotinin reduced packed red blood cell transfusions more than tranexamic acid, although the difference did not reach statistical significance. Only aprotinin significantly reduced the proportion of transfused patients when compared with placebo (mean difference –20.9%, 95% CI 7.3–33.5; p = 0.013), and only aprotinin completely abolished bleeding-related re-explorations (mean difference 6.8%, 95% CI 1.6–13.4%; p = 0.004). Neither antifibrinolytic agent increased the incidence of mortality (mean difference tranexamic acid –0.4%, 95% CI –4.6 to 4.4; p = 0.79, mean difference aprotinin –1.3%, 95% CI –6.2 to 3.5; p = 0.62) or other serious adverse events when compared with placebo. Conclusion: Aprotinin has clinically significant advantages over tranexamic acid in patients with normal renal function scheduled for low- or intermediate-risk cardiac surgery.

Key Words: Surgical blood loss • Postoperative blood loss • Antifibrinolytic agents • Blood transfusion

This article has been cited by other articles:

				P. Kempaiah, L. A. Danielson, M. Barry, and W. Kisiel Comparative Effects of Aprotinin and Human Recombinant R24K KD1 on Temporal Renal Function in Long-Evans Rats J. Pharmacol. Exp. Ther., December 1, 2009; 331(3): 940 - 945. [Abstract] [Full Text] [PDF]

				J. R. Brown Mortality manifesto: a meta-analysis of aprotinin and tranexamic acid mortality Eur. J. Cardiothorac. Surg., October 1, 2009; 36(4): 781 - 782. [Full Text] [PDF]