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

This Article Full Text 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 Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Cary W. Akins Eugene H. Blackstone Lawrence H. Cohn Delos M. Cosgrove Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by D'Ambra, M. N. Articles by Maddi, R. Search for Related Content PubMed PubMed Citation Articles by D'Ambra, M. N. Articles by Maddi, R.

J Thorac Cardiovasc Surg 1996;112:1081-1089
© 1996 Mosby, Inc.

CARDIOPULMONARY BYPASS, MYOCARDIAL MANAGEMENT, AND SUPPORT TECHNIQUES

APROTININ IN PRIMARY VALVE REPLACEMENT AND RECONSTRUCTION: A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Research supported in part by grants from Miles Inc., West Haven, Conn., and Rowland Foundation, Cambridge, Mass.

Received for publication Oct. 19, 1995 Revisions requested Dec. 26, 1995; revisions received May 3, 1996 Accepted for publication May 6, 1996. Address for reprints: Michael N. D'Ambra, MD, Cardiac Anesthesia Group, Massachusetts General Hospital, Boston, MA 02114-2696.

Abstract

Background: Patients having cardiac operations often require blood transfusions. Aprotinin reduces the need for blood transfusions during coronary artery bypass graft operations. To determine the safety and effectiveness of aprotinin in reducing the use of allogeneic blood and postoperative mediastinal chest tube drainage, we studied 212 patients undergoing primary sternotomy for valve replacement or repair.

Methods: This study was multicenter, randomized, prospective, double-blind, and placebo-controlled. Patients received high-doseaprotinin (n = 71), low-dose aprotinin (n = 70), or placebo (n = 71). The study medication was given as a loading dose followed by a continuous infusion and pump prime dose. Heparin administration was standardized. Transfusions, postoperative mediastinal shed blood, and adverse events were tracked.

Results: Demographic profiles were similar among the treatment groups. Aprotinin did not decrease the percentage of patients receiving transfusions when compared with placebo (high-dose aprotinin, 63%, p = 0.092; low-dose aprotinin, 52%, p = 0.592; placebo, 48%). Aprotinin was associated with a reduction in the volume of mediastinal shed blood (high-dose aprotinin vs placebo, p = 0.002; low-dose aprotinin vs placebo, p = 0.017). Adverse events were equally distributed among the treatment groups except for postoperative renal dysfunction (high-dose aprotinin, 11%; low-dose aprotinin, 7%; placebo, 0%; p = 0.01). A disproportionate number of patients in the high-dose aprotinin group with postoperative renal dysfunction also had diabetes mellitus.

Conclusions: Aprotinin treatment in this population did not reduce allogeneic blood use, although there were significant reductions in the volume of mediastinal shed blood. (J THORACCARDIOVASCSURG1996;112:1081-9)

This article has been cited by other articles:

				D. L. Ngaage, A. R. Cale, M. E. Cowen, S. Griffin, and L. Guvendik Aprotinin in Primary Cardiac Surgery: Operative Outcome of Propensity Score-Matched Study Ann. Thorac. Surg., October 1, 2008; 86(4): 1195 - 1202. [Abstract] [Full Text] [PDF]

				M. D. McEvoy, S. T. Reeves, J. G. Reves, and F. G. Spinale Aprotinin in Cardiac Surgery: A Review of Conventional and Novel Mechanisms of Action Anesth. Analg., October 1, 2007; 105(4): 949 - 962. [Abstract] [Full Text] [PDF]

				J. R. Brown, N. J.O. Birkmeyer, and G. T. O'Connor Meta-Analysis Comparing the Effectiveness and Adverse Outcomes of Antifibrinolytic Agents in Cardiac Surgery Circulation, June 5, 2007; 115(22): 2801 - 2813. [Abstract] [Full Text] [PDF]

				P. M. Mannucci and M. Levi Prevention and Treatment of Major Blood Loss N. Engl. J. Med., May 31, 2007; 356(22): 2301 - 2311. [Full Text] [PDF]

				The Society of Thoracic Surgeons Blood Conservatio, V. A. Ferraris, S. P. Ferraris, S. P. Saha, E. A. Hessel II, C. K. Haan, B. D. Royston, C. R. Bridges, R. S.D. Higgins, G. Despotis, et al. Perioperative Blood Transfusion and Blood Conservation in Cardiac Surgery: The Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists Clinical Practice Guideline Ann. Thorac. Surg., May 1, 2007; 83(5_Supplement): S27 - S86. [Abstract] [Full Text] [PDF]

				S. C. Body and C. D. Mazer Pro: Aprotinin Has a Good Efficacy and Safety Profile Relative to Other Alternatives for Prevention of Bleeding in Cardiac Surgery Anesth. Analg., December 1, 2006; 103(6): 1354 - 1359. [Full Text] [PDF]

				Y. Abu-Omar and C. Ratnatunga Cardiopulmonary Bypass and Renal Injury Perfusion, July 1, 2006; 21(4): 209 - 213. [Abstract] [PDF]

				V. A. Ferraris, C. R. Bridges, R. P. Anderson, for the Blood Conservation Guideline, J. R. Brown, N. J.O. Birkmeyer, G. T. O'Connor, J. H. Levy, J. G. Ramsay, R. A. Guyton, et al. Aprotinin in cardiac surgery. N. Engl. J. Med., May 4, 2006; 354(18): 1953 - 1957. [Full Text] [PDF]

				D. T. Mangano, I. C. Tudor, C. Dietzel, and the Multicenter Study of Perioperative Ischemia Re The Risk Associated with Aprotinin in Cardiac Surgery N. Engl. J. Med., January 26, 2006; 354(4): 353 - 365. [Abstract] [Full Text] [PDF]

				A. Kher, K. K. Meldrum, K. L. Hile, M. Wang, B. M. Tsai, M. W. Turrentine, J. W. Brown, and D. R. Meldrum Aprotinin improves kidney function and decreases tubular cell apoptosis and proapoptotic signaling after renal ischemia-reperfusion J. Thorac. Cardiovasc. Surg., September 1, 2005; 130(3): 662 - 662. [Abstract] [Full Text] [PDF]

				E. L. Gillespie, K. A. Gryskiewicz, C. M. White, J. Kluger, C. Humphrey, S. Horowitz, and C. I. Coleman Effect of aprotinin on the frequency of postoperative atrial fibrillation or flutter Am. J. Health Syst. Pharm., July 1, 2005; 62(13): 1370 - 1374. [Abstract] [Full Text] [PDF]

				D. Fergusson, K. C. Glass, B. Hutton, and S. Shapiro Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding? Clinical Trials, June 1, 2005; 2(3): 218 - 232. [Abstract] [PDF]

				D. P. Taggart, V. Djapardy, M. Naik, and A. Davies A randomized trial of aprotinin (Trasylol) on blood loss, blood product requirement, and myocardial injury in total arterial grafting J. Thorac. Cardiovasc. Surg., October 1, 2003; 126(4): 1087 - 1094. [Abstract] [Full Text] [PDF]

				S. M. Beath, G. A. Nuttall, D. N. Fass, W. C. Oliver Jr., M. H. Ereth, and L. J. Oyen Plasma Aprotinin Concentrations During Cardiac Surgery: Full- Versus Half-Dose Regimens Anesth. Analg., August 1, 2000; 91(2): 257 - 264. [Abstract] [Full Text] [PDF]

				J. J. Munoz, N. J. O. Birkmeyer, J. D. Birkmeyer, G. T. O'Connor, and L. J. Dacey Is {epsilon}-Aminocaproic Acid as Effective as Aprotinin in Reducing Bleeding With Cardiac Surgery? : A Meta-Analysis Circulation, January 12, 1999; 99(1): 81 - 89. [Abstract] [Full Text] [PDF]

				T. K. Rosengart, W. DeBois, M. O'Hara, R. Helm, M. Gomez, S. J. Lang, N. Altorki, W. Ko, G. S. Hartman, O. W. Isom, et al. Retrograde Autologous Priming For Cardiopulmonary Bypass: A Safe And Effective Means Of Decreasing Hemodilution And Transfusion Requirements J. Thorac. Cardiovasc. Surg., February 1, 1998; 115(2): 426 - 439. [Abstract] [Full Text] [PDF]