title: A prospective study of the risk of an immediate adverse reaction to protamine sulfate during cardiopulmonary bypass surgery.
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.
authors.affiliation: Department of Medicine, University of Iowa, Iowa City.
authors.forename: J M
authors.initials: JM
authors.lastname: Weiler
authors.forename: M A
authors.initials: MA
authors.lastname: Gellhaus
authors.forename: J G
authors.initials: JG
authors.lastname: Carter
authors.forename: R L
authors.initials: RL
authors.lastname: Meng
authors.forename: P M
authors.initials: PM
authors.lastname: Benson
authors.forename: R A
authors.initials: RA
authors.lastname: Hottel
authors.forename: K B
authors.initials: KB
authors.lastname: Schillig
authors.forename: A B
authors.initials: AB
authors.lastname: Vegh
authors.forename: W R
authors.initials: WR
authors.lastname: Clarke
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002315:Cardiopulmonary Bypass / Q000009:adverse effects; D003167:Complement Activation; D015926:Complement C3a / Q000032:analysis; D015934:Complement C4a / Q000032:analysis; D015936:Complement C5a / Q000032:analysis; D048909:Diabetes Complications; D003920:Diabetes Mellitus / Q000276:immunology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D006969:Hypersensitivity, Immediate / Q000209:etiology* / Q000276:immunology; D007073:Immunoglobulin E / Q000032:analysis; D007328:Insulin / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011479:Protamines / Q000009:adverse effects* / Q000276:immunology; D012307:Risk Factors; D012882:Skin Tests; D013997:Time Factors
chemical_list: D007328:Insulin; D011479:Protamines; D007073:Immunoglobulin E; D015926:Complement C3a; D015934:Complement C4a; D015936:Complement C5a