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Hemostatic agents and their safety.

J H Levy1

  • 1Department of Anesthesiology, Emory University School of Medicine, Atlanta, GA, USA.

Journal of Cardiothoracic and Vascular Anesthesia
|September 1, 1999
PubMed
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Evaluating hemostatic agents like aprotinin and protamine is crucial for patient safety during cardiopulmonary bypass. Objective safety profiles show aprotinin has no increased risk of major adverse events in US studies, though anaphylaxis is possible.

Area of Science:

  • Cardiovascular Surgery
  • Pharmacology
  • Anesthesiology

Background:

  • Pharmacologic management of hemostasis during cardiopulmonary bypass (CPB) can lead to adverse events.
  • Objective evaluation of hemostatic agents, including lysine analogs, aprotinin, protamine, and donor blood, is essential.

Purpose of the Study:

  • To objectively evaluate the safety profile of hemostatic agents used in patients undergoing cardiopulmonary bypass.
  • To review the established safety data for aprotinin and protamine, considering potential adverse reactions.

Main Methods:

  • Review of multiple double-blind, placebo-controlled, multicenter studies on aprotinin.
  • Analysis of large-scale patient data to define adverse reactions to protamine.
  • Consideration of adverse reactions associated with blood products.

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Main Results:

  • Aprotinin, a serine protease inhibitor, is associated with decreased fibrinolysis but not increased risks of myocardial infarction, graft closure, stroke, or renal dysfunction in US studies.
  • Anaphylaxis is a potential risk with aprotinin, influenced by prior exposure.
  • Large patient studies have clarified adverse reactions to protamine.

Conclusions:

  • Objective safety evaluations are necessary for hemostatic agents used in CPB.
  • While aprotinin demonstrates a favorable safety profile in US studies regarding major adverse events, anaphylaxis remains a consideration.
  • Adverse reactions to protamine and blood products must be factored into safety comparisons.