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  • Title: A prospective study of the risk of an immediate adverse reaction to protamine sulfate during cardiopulmonary bypass surgery.
    Author: Weiler JM, Gellhaus MA, Carter JG, Meng RL, Benson PM, Hottel RA, Schillig KB, Vegh AB, Clarke WR.
    Journal: J Allergy Clin Immunol; 1990 Apr; 85(4):713-9. PubMed ID: 2182695.
    Abstract:
    Protamine sulfate administration may cause life-threatening reactions. We prospectively examined the incidence of immediate adverse reaction after protamine in 243 patients who underwent cardiopulmonary bypass surgery. Twenty-six patients (10.7%) had reactions, and 1.6% had a precipitous drop in blood pressure immediately after protamine administration. Risk factors were previous exposure to protamine, diabetes, history of receiving protamine-containing insulin, and possibly vasectomy. However, neither a positive skin test nor a positive IgE ELISA for antiprotamine antibody predicted that a patient would have a reaction. C4a levels were increased in patients who had reactions as compared with age-, sex-, and cardiac disease-matched patients who did not have reactions, suggesting a role for complement in some reactions. Immediate adverse reactions to protamine are very common, and alternative therapies are urgently needed to eliminate the use of protamine.
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