Table 4.

Key age and disease specific management issues and areas of future study of DOACs

Special populationClinical challenges and future research needs
Age groups  
Neonates 
  • PK and PD in gestational age <37 wk

  • Safety in the presence of comorbidities

    • Critically ill or on mechanical ventilation

    • Absorption with naso-jejunum tube feeding

    • Presence of arterial central lines

    • Sepsis

  • Access to liquid formulation or sprinkles

  • Management surrounding invasive procedures and surgeries

  • Impact on growth and development, immune function, and bone health

 
Toddler/young child 
  • Availability of a liquid formulation or pellets

  • Safety with noncontact activities; eg, in school or on the playground

 
Teenager 
  • Safety for athletes playing contact sports

  • Management of menstrual bleeding (in young women)

  • Impact on quality of life

  • Safety in the presence of high-risk behavior

  • Optimal contraceptive options

  • Safety with use of concomitant antifibrinolytics

 
Medical comorbidities  
Cancer 
  • Safety with chemotherapy induced toxicity affecting different organ systems, for example, liver, kidney, and GI, thrombocytopenia, concomitant medications, and sepsis

  • Periprocedural management

 
Renal/liver dysfunction, GI malabsorption, or short gut 
  • Use in mild or moderate renal and liver dysfunction

  • PK/PD in GI malabsorption and short gut

  • Key safety considerations

 
Special populationClinical challenges and future research needs
Age groups  
Neonates 
  • PK and PD in gestational age <37 wk

  • Safety in the presence of comorbidities

    • Critically ill or on mechanical ventilation

    • Absorption with naso-jejunum tube feeding

    • Presence of arterial central lines

    • Sepsis

  • Access to liquid formulation or sprinkles

  • Management surrounding invasive procedures and surgeries

  • Impact on growth and development, immune function, and bone health

 
Toddler/young child 
  • Availability of a liquid formulation or pellets

  • Safety with noncontact activities; eg, in school or on the playground

 
Teenager 
  • Safety for athletes playing contact sports

  • Management of menstrual bleeding (in young women)

  • Impact on quality of life

  • Safety in the presence of high-risk behavior

  • Optimal contraceptive options

  • Safety with use of concomitant antifibrinolytics

 
Medical comorbidities  
Cancer 
  • Safety with chemotherapy induced toxicity affecting different organ systems, for example, liver, kidney, and GI, thrombocytopenia, concomitant medications, and sepsis

  • Periprocedural management

 
Renal/liver dysfunction, GI malabsorption, or short gut 
  • Use in mild or moderate renal and liver dysfunction

  • PK/PD in GI malabsorption and short gut

  • Key safety considerations

 

PD, pharmacodynamic.

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