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Safety of aprotinin in congenital heart operations: results from a large multicenter database
Sara K Pasquali1, Matthew Hall, Jennifer S Li
1Division of Pediatric Cardiology, Duke University Medical Center, Durham, North Carolina 27715, USA. sara.pasquali@duke.edu
Insights
Aprotinin did not increase mortality or dialysis needs in pediatric heart surgery patients. Further studies on aprotinin use in children undergoing congenital heart operations can proceed safely.
Area of Science:
- Pediatric Cardiac Surgery
- Pharmacology
- Clinical Outcomes Research
Background:
- Aprotinin was previously used to reduce bleeding in pediatric cardiac surgery.
- Concerns arose from adult studies showing increased renal failure and death.
- This study reassesses aprotinin's safety in children undergoing congenital heart operations.
Purpose of the Study:
- To evaluate the safety of aprotinin in children undergoing congenital heart operations.
- To determine associations between aprotinin use and in-hospital mortality, postoperative dialysis, and length of stay.
- To assess safety in a high-risk subgroup undergoing reoperation.
Main Methods:
- Retrospective cohort study using the Pediatric Health Information Systems Database (2003-2007).
- Included 30,372 children (0-18 years) undergoing congenital heart operations at 35 centers.
- Propensity score and multivariable analyses adjusted for confounders to assess outcomes.
Main Results:
- No significant differences in mortality or dialysis were found between aprotinin recipients and non-recipients.
- Aprotinin use was not associated with increased length of stay overall.
- In a high-risk reoperation subgroup, aprotinin recipients had a significantly reduced length of stay.
Conclusions:
- Aprotinin is not associated with increased mortality or dialysis in pediatric cardiac surgery patients.
- Further investigation of aprotinin in this population is warranted.
- Aprotinin may offer benefits in reducing length of stay for reoperations.
Background:
Aprotinin was used frequently in children undergoing congenital heart operations with the aim of reducing bleeding, until it was taken off the market after adult studies reported increased renal failure and death. We evaluated the safety of aprotinin in a large multicenter cohort of children undergoing congenital heart operations.
Methods:
The Pediatric Health Information Systems Database was used to evaluate aprotinin in children (aged 0 to 18 years) undergoing congenital heart operations at 35 children's hospitals from 2003 to 2007. Propensity scores were constructed to account for potential confounders of age, sex, race, prematurity, genetic syndrome, type of operation (Risk Adjustment in Congenital Heart Surgery-1 category), center, and center volume. Multivariable analysis, adjusting for propensity score and individual covariates was performed to evaluate in-hospital mortality, postoperative renal failure requiring dialysis, and length of stay. Subanalysis was performed in the high-risk cohort undergoing reoperation.
Results:
The study included 30,372 patients (56% male) who were a median age of 7 months (interquartile range, 36 days to 3.2 years). Overall, 44% received aprotinin. Multivariable analysis found no difference in postoperative mortality (odds ratio, 1.00; 95% confidence interval [CI], 0.99 to 1.01), dialysis (odds ratio, 1.00; 95% CI, 0.99 to 1.01), or length of stay (least square mean difference, -0.44 days; 95% CI, -1.01 to 0.13) between aprotinin recipients and nonrecipients. No difference was found in mortality or dialysis in patients undergoing reoperation. Aprotinin recipients in the reoperation subgroup had significantly reduced length of stay (least square mean difference, -2.05 days; 95% CI -3.29 to -0.81),
Conclusions:
These data suggest aprotinin is not associated with increased mortality or dialysis in children undergoing congenital heart operations and that further evaluation of aprotinin in this population could be undertaken without undue risk.
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