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Thrombotic Complications of Low-Dose Versus High-Dose Four-Factor Prothrombin Complex Concentrate for Massive

Laura Palacio-Guzmán1,2,3, Sergio Alzate-Ricaurte3, Natalia Plata-Ayala1,2,3

  • 1Anesthesiology Department, Fundación Valle del Lili, Cali, Colombia.

Paediatric Anaesthesia
|May 28, 2025
PubMed

Insights

Four-factor prothrombin complex concentrates (4F-PCC) effectively manage severe bleeding in pediatric cardiovascular surgery without increasing thrombotic risks. This study found no significant difference in thrombotic complications between high-dose and low-dose 4F-PCC administration.

Area of Science:

  • Cardiology
  • Hematology
  • Pediatric Surgery

Background:

  • Pediatric cardiovascular surgery, especially in neonates and infants with congenital heart defects (CHD), faces significant risks of life-threatening bleeding.
  • Cardiopulmonary bypass (CPB) can worsen bleeding by depleting coagulation factors and platelets.
  • Four-factor prothrombin complex concentrates (4F-PCC) offer targeted hemostasis but may pose thrombotic risks.

Purpose of the Study:

  • To evaluate the safety and efficacy of four-factor prothrombin complex concentrates (4F-PCC) in managing severe bleeding during pediatric cardiovascular surgery.
  • To compare thrombotic complication rates between low-dose and high-dose 4F-PCC administration in pediatric patients.

Main Methods:

  • A retrospective cohort study analyzed 104 pediatric patients who received 4F-PCC after cardiovascular surgery between January 2018 and April 2024.
  • Patients were categorized into low-dose (<35 U/kg) and high-dose (≥35 U/kg) 4F-PCC groups.
  • Thrombotic complications were assessed within 15 days post-administration.

Main Results:

  • Overall thrombotic complications occurred in 6.73% of patients, lower than the 11% all-cause thrombotic complication rate in pediatric cardiovascular surgery.
  • No significant difference in thrombotic complications was observed between the high-dose (5.26%) and low-dose (8.51%) groups (p=0.698).
  • High-dose 4F-PCC was linked to shorter CPB times but higher reintervention rates.

Conclusions:

  • Four-factor prothrombin complex concentrates (4F-PCC) appear to be a safe and viable option for managing severe bleeding in pediatric cardiovascular surgery.
  • The study did not find evidence of increased thrombotic risk with higher doses of 4F-PCC.
  • Further research is warranted to optimize 4F-PCC dosing and explore its preventive applications in this patient population.
Abstract

Keywords:
cardiovascular surgical procedurespediatric anesthesiaprothrombin complex concentratessurgical blood lossthrombosis

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