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Published on: September 9, 2012
Use of Factor VIIa and Anti-inhibitor Coagulant Complex in Pediatric Cardiac Surgery Patients
Insights
Recombinant activated clotting factor VIIa (rFVIIa) and anti-inhibitor coagulant complex (FEIBA) reduced blood product use in pediatric cardiac surgery patients. These agents may help manage bleeding after cardiopulmonary bypass, though thrombus risk exists.
Area of Science:
- Cardiovascular Surgery
- Pediatric Hematology
- Pharmacology
Background:
- Postoperative bleeding is a significant risk in pediatric cardiac surgery patients undergoing cardiopulmonary bypass (CPB).
- Pediatric patients are particularly vulnerable to CPB-related coagulation system disturbances, leading to increased bleeding and transfusion needs.
- Off-label use of recombinant activated clotting factor VIIa (rFVIIa) and anti-inhibitor coagulant complex (FEIBA) is considered for refractory bleeding, but pediatric data are limited.
Purpose of the Study:
- To evaluate the efficacy and safety of off-label rFVIIa and FEIBA in pediatric patients undergoing cardiac surgery.
- To report institutional experience with these agents in managing bleeding unresponsive to conventional therapies.
Main Methods:
- Retrospective chart review of pediatric cardiothoracic surgery patients who received rFVIIa or FEIBA.
- Data collected on patient demographics, bleeding management, blood product administration, and outcomes.
Main Results:
- Thirty-three patients received rFVIIa, and 9 received FEIBA for cardiac procedure-related bleeding.
- Both agents were associated with decreased blood product administration post-treatment.
- Thrombus events occurred in 17% of rFVIIa patients and 22% of FEIBA patients.
Conclusions:
- rFVIIa and FEIBA effectively reduced blood product usage in pediatric cardiac surgery patients.
- These agents represent a viable option for managing refractory bleeding in this population, warranting further investigation into risk-benefit profiles.
Objectives:
Postoperative bleeding is a common cause of morbidity and mortality in cardiac patients who undergo cardiopulmonary bypass (CPB). Pediatric patients are especially at risk for adverse effects of surgery and CPB on the coagulation system. This can result in bleeding, transfusions, and poor outcomes. Excessive bleeding unresponsive to blood products can warrant the off-label use of recombinant activated clotting factor VIIa (rFVIIa) and/or anti-inhibitor coagulant complex (FEIBA). Several studies have shown the utility in these agents off-label in patients who have undergone cardiac bypass surgery with acute bleeding episodes that are refractory to blood products. However, data regarding use of these agents in pediatrics are sparse. The purpose of this study is to report the use of rFVIIa and FEIBA in pediatric cardiac surgery patients in our institution.
Methods:
This was a retrospective chart review of pediatric cardiothoracic surgery patients who received rFVIIa or FEIBA at Children's Healthcare of Atlanta during the study period.
Results:
Thirty-three patients received rFVIIa and 9 patients received FEIBA either intraoperatively or postoperatively for bleeding related to the cardiac procedure. Approximately 13% of rFVIIa patients and 55% of FEIBA patients required repeat doses. There were decreases for all blood products administered after rFVIIa and FEIBA were given. However, the doses used did not correlate with either positive or negative outcomes. Seventeen percent (n = 7) of rFVIIa patients experienced a thrombus and 22% (n = 2) of FEIBA patients experienced a thrombus.
Conclusions:
Both rFVIIa and FEIBA reduced blood product usage in pediatric patients following cardiac procedures.
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