Aprotinin-Free Alternative for Vascular Surgery

An aprotinin-free fibrin sealant, approved for use in vascular surgery, could save thousands of lives each year in cardiac surgery alone.

Evicel, a fibrin sealant for topical use, has been approved by the U.S. Food and Drug Administration (FDA) as an adjunct to hemostasis for use in patients undergoing liver or vascular surgery, when control of bleeding by standard surgical techniques is ineffective or impractical. The sealant should be applied by either spraying short bursts (0.1-0.2 ml) or dripping on the surface of bleeding tissue only, to produce a thin even layer. If the hemostatic effect is not complete, a second layer should be applied. The sealant is not to be injected directly into the circulatory system.

Evicel is supplied as a kit consisting of two separate packages, each containing one vial of Biologically Active Component 2 (BAC2; 55-85 mg/ml fibrinogen) and one vial of thrombin (800-1200 IU/ml human thrombin) frozen solutions. The components need to be thawed shortly prior to usage, and unused contents discarded. A clog-resistant catheter design eliminates the inconvenience of switching tips for delivery.

Since Evicel is a plasma-based product, it should not be used in individuals known to have anaphylactic or severe systemic reaction to human blood products, and may carry a risk of transmitting infectious agents. Evicel is manufactured Omrix Biopharmaceuticals (New York, NY, USA).

Aprotinin is a bovine source antifibrinolytic agent that has been used to help reduce bleeding during surgery since the mid-1980s. Two recent studies have suggested that patients treated with aprotinin could be at higher risk of serious health problems including kidney failure, heart attack, stroke, anaphylactic shock, and even death; the risk could increase dramatically with repeat exposure.


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Omrix Biopharmaceuticals