Adverse events after protamine administration following cardiopulmonary bypass in infants and children.
We performed this study to determine the incidence of and risk factors for adverse events (AEs) in infants and children after the IV administration of protamine after cardiopulmonary bypass. In a retrospective cohort study, all relevant anesthesia records from a 3-yr period were examined to identify AEs after protamine. The AEs were then grouped into three categories by applying increasingly strict criteria. Among 1249 anesthesia records, there were no documented episodes of isolated or hypotension-associated right-sided cardiac failure or acute pulmonary dysfunction. The incidence of systemic hypotension after protamine was between 1.76% (95% confidence interval [CI], 1.11%-2.65%) and 2.88% (95% CI, 2.03%-3.97%), depending on the strictness of case definition. To identify risk factors, we performed a nested case-control study in which unmatched controls were randomly selected from the parent cohort at a 4:1 ratio to cases. Cases of hypotension after protamine were more likely during operations on girls (odds ratio [OR], 6.47; 95% CI, 1.66-32.8), after larger doses of protamine (OR, 1.88; 95% CI, 1.03-3.63), or after smaller doses of heparin (OR, 0.49; 95% CI, 0.17-0.67).


CONCLUSIONS
Systemic hypotension after protamine administration occurred in 1.76%-2.88% of pediatric patients having cardiac surgery. Female sex, larger protamine dose, and smaller heparin dose were each associated with increased risk. The development of protamine alternatives or prophylactic therapies may be useful for reducing the frequency of these events.
Seifert
Harry A
HA
*Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania; and †Division of Cardiothoracic Anesthesiology, Department of Anesthesiology & Critical Care, The Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, Pennsylvania.
Jobes
David R
DR
Ten Have
Thomas
T
Kimmel
Stephen E
SE
Montenegro
Lisa M
LM
Steven
James M
JM
Nicolson
Susan C
SC
Strom
Brian L
BL
D000293:Adolescent; D002315:Cardiopulmonary Bypass; D016022:Case-Control Studies; D002648:Child; D002675:Child, Preschool; D005260:Female; D006494:Heparin Antagonists / Q000009:adverse effects*; D006801:Humans; D007022:Hypotension / Q000139:chemically induced; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D015999:Multivariate Analysis; D016017:Odds Ratio; D011479:Protamines / Q000009:adverse effects*; D012189:Retrospective Studies; D012307:Risk Factors
D006494:Heparin Antagonists; D011479:Protamines