Related Experiment Video
Updated: Sep 21, 2026
Pediatric Animal Model of Extracorporeal Cardiopulmonary Resuscitation After Prolonged Circulatory Arrest
Published on: May 26, 2023
Adverse events after protamine administration following cardiopulmonary bypass in infants and children
Harry A Seifert1, David R Jobes, Thomas Ten Have
1*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.
Insights
Systemic hypotension occurred in 1.76%-2.88% of pediatric cardiac surgery patients after protamine administration. Female sex, higher protamine doses, and lower heparin doses increased this risk, suggesting a need for alternative therapies.
Area of Science:
- Pediatric Anesthesiology
- Cardiovascular Surgery
- Pharmacology
Background:
- Adverse events (AEs) following protamine administration after cardiopulmonary bypass in pediatric patients require thorough investigation.
- Understanding the incidence and risk factors for these AEs is crucial for patient safety.
Purpose of the Study:
- To determine the incidence of AEs in infants and children after intravenous protamine administration post-cardiopulmonary bypass.
- To identify risk factors associated with protamine-induced adverse events, specifically systemic hypotension.
Main Methods:
- Retrospective cohort study analyzing 1249 anesthesia records over a 3-year period.
- AEs were categorized using increasingly strict criteria.
- A nested case-control study identified risk factors for hypotension.
Main Results:
- No documented cases of isolated right-sided cardiac failure or acute pulmonary dysfunction were observed.
- The incidence of systemic hypotension ranged from 1.76% to 2.88%, depending on the definition used.
- Risk factors for hypotension included female sex (OR 6.47), larger protamine doses (OR 1.88), and smaller heparin doses (OR 0.49).
Conclusions:
- Systemic hypotension is a notable adverse event in pediatric cardiac surgery patients receiving protamine, occurring in 1.76%-2.88% of cases.
- Female sex, higher protamine dosage, and lower heparin dosage are significant risk factors.
- Developing alternative protamine agents or prophylactic treatments could mitigate these adverse events.
Unlabelled:
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).
Implications:
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.
Related Concept Videos
01:28Cardiac Catheterization I: Pre-Procedure Overview
01:28Cardiomyopathy VII: Pre and Post Operative Nursing Management
01:25Cardiopulmonary Resuscitation IV: Pharmacological Management
01:21Cardiac Catheterization II: Right Heart Catheterization
01:26Cardiac Catheterization IV: Nursing Management
01:21Skeletal Muscle Relaxants: Adverse Effects
Unlike...