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Activated 4-factor prothrombin complex concentrate (a4FPCC) reduced blood product transfusions in neonates after cardiac surgery. This hemostatic therapy did not increase thromboembolism risk, suggesting its potential for managing refractory bleeding.

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Area of Science:

  • Cardiology
  • Pediatric Surgery
  • Hematology

Background:

  • Prothrombin complex concentrates are increasingly used off-label to improve hemostasis post-cardiopulmonary bypass (CPB).
  • Limited data exist on their efficacy and safety in neonatal cardiac surgery.

Purpose of the Study:

  • To evaluate the effectiveness of activated 4-factor prothrombin complex concentrate (a4FPCC) in reducing blood product transfusions.
  • To assess the safety of a4FPCC regarding thromboembolic events in neonates undergoing cardiac surgery.

Main Methods:

  • Retrospective review of neonates undergoing open heart surgery with first-time sternotomy.
  • Propensity score matching (PSM) to compare a4FPCC recipients with a control group.
  • Primary outcomes: total blood products transfused and 7/30-day postoperative thromboembolism rates.

Main Results:

  • The a4FPCC group (n=43) showed significantly lower mean total blood products transfused (47.5 mL/kg) compared to the control group (63.7 mL/kg).
  • No significant difference in 7- or 30-day thromboembolic rates, postoperative bleeding, extubation time, AKI, or mortality was observed.
  • The a4FPCC group experienced longer intensive care unit and hospital stays.

Conclusions:

  • a4FPCC use was associated with reduced blood product transfusion needs after CPB in neonatal cardiac surgery.
  • This hemostatic adjunct did not increase the risk of postoperative thromboembolism.
  • a4FPCC may be considered for refractory bleeding in this patient population.