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The in-vitro anticoagulant effect of rivaroxaban in neonates

Chantal Attard1, Paul Monagle, Dagmar Kubitza

  • 1aMurdoch Childrens Research Institute, Royal Children's Hospital bDepartment of Paediatrics, The University of Melbourne, Royal Children's Hospital cDepartment of Clinical Haematology, Royal Children's Hospital, Parkville, Victoria, Australia dBayer Pharma AG, Global Drug Discovery, Clinical Pharmacology, Cardiovascular/Primary Care, Wuppertal, Germany.

Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis
|January 15, 2014
PubMed

Insights

Rivaroxaban, a direct Factor Xa inhibitor, shows age-related differences in anticoagulant effects in vitro. Neonates exhibit increased clotting times compared to adults, necessitating further in-vivo studies for this vulnerable population.

Area of Science:

  • Neonatal pharmacology
  • Hematology
  • Pharmacodynamics

Background:

  • Increasing use of anticoagulants in neonates due to advances in critical care.
  • Current neonatal anticoagulation is suboptimal due to physiological and pharmacological differences.
  • Novel anticoagulants targeting specific coagulation factors are under development.

Purpose of the Study:

  • To investigate age-related differences in the in vitro pharmacodynamic effects of rivaroxaban in neonatal plasma.
  • To compare the impact of rivaroxaban on coagulation parameters in neonates versus adults.
  • To assess the potential of rivaroxaban as an anticoagulant in the neonatal population.

Main Methods:

  • Creation of neonatal and adult plasma pools.
  • Spiking plasma pools with increasing concentrations of rivaroxaban (0-500 ng/ml).
  • Measurement of rivaroxaban effects using prothrombin time (PT), activated partial thromboplastin time (aPTT), anti-Factor Xa assays, and thrombin generation assays.

Main Results:

  • A dose-dependent response to rivaroxaban was observed for PT, aPTT, and lag time in both neonatal and adult groups.
  • Rivaroxaban significantly increased PT and aPTT clotting times in neonates compared to adults.
  • Thrombin generation assays showed a significant increase in lag time with rivaroxaban in neonates versus adults.

Conclusions:

  • Rivaroxaban demonstrates distinct in vitro pharmacodynamic effects in neonatal plasma compared to adult plasma.
  • Neonates show a heightened sensitivity to rivaroxaban's anticoagulant effects.
  • Further in-vivo studies are essential to validate these findings and establish safe and effective dosing in neonates.

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