A benefit-risk review of systemic haemostatic agents - Part 1: In major surgery

被引:22
作者
Fraser, Ian S. [1 ]
Porte, Robert J. [2 ]
Kouides, Peter A. [3 ]
Lukes, Andrea S. [4 ]
机构
[1] Univ Sydney, Dept Obstet & Gynaecol, Sydney, NSW 2006, Australia
[2] Univ Groningen, Univ Med Ctr Groningen, Dept Surg, Groningen, Netherlands
[3] Mary M Gooely Hemophilia Ctr Rochester, Rochester, NY USA
[4] Carolina Womens Res & Wellness Ctr, Durham, NC USA
关键词
D O I
10.2165/00002018-200831030-00003
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 [公共卫生与预防医学]; 120402 [社会医学与卫生事业管理];
摘要
Systemic haemostatic agents play an important role in the management of blood loss during major surgery where significant blood loss is likely and their use has increased in recent times as a consequence of demand for blood products outstripping supply and the risks associated with transfusions. Their main application is as prophylaxis to reduce bleeding in major surgery, including cardiac and orthopaedic surgery and orthotopic liver transplantation. Aprotinin has been the predominant agent used in this setting; of the other antifibrinolytic agents that have been studied, tranexamic acid is the most effective and epsilon-aminocaproic acid may also have a role. Eptacog alfa (recombinant factor VIIa) has also shown promise. Tranexamic acid, epsilon-aminocaproic acid and eptacog alfa are generally well tolerated; however, when considering the methods to reduce or prevent blood loss intra- and postoperatively, the benefits of these agents need to be weighed against the risk of adverse events. Recently, concerns have been raised about the safety of aprotinin after an association between increased renal dysfunction and mortality was shown in retrospective observational studies and an increase in all-cause mortality with aprotinin relative to tranexamic acid or F-aminocaproic acid was seen after a pre-planned periodic analysis of the large BART (Blood conservation using Antifibrinolytics in a Randomized Trial) study. The latter finding resulted in the trial being halted, and aprotinin has subsequently been withdrawn from the market pending detailed analysis of efficacy and safety results from the study. Part I of this benefit-risk review examines the efficacy and adverse effect profiles of systemic haemostatic agents commonly used in surgery, and provides individual benefit-risk profiles that may assist clinicians in selecting appropriate pharmacological therapy in this setting.
引用
收藏
页码:217 / 230
页数:14
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