Eligibility

Inclusion criteria

  • Age 16 and younger
  • Body weight of 3-80 kilograms
  • VA-ECMO use for primary cardiac failure using the Cardiohelp system
  • First ECMO run during any hospitalization
  • Written informed consent from the parent or LAR (legally authorized representative)

Exclusion criteria

A child is not eligible to participate because of any of the following circumstances:

  • Gestationally-corrected age <37 weeks
  • Bleeding or coagulopathy that is a contraindication to anticoagulation
  • Irreversible renal, hepatic, or lung failure
  • Stroke or uncertain neurological status within the past 30 days
  • Severely malnourished
  • Use of an ECMO system other than the Cardiohelp
  • VV-ECMO or ECMO for primary respiratory failure
  • Goals of patient to focus on comfort measures only
  • Failure to separate from cardiopulmonary bypass
  • Allergy or contraindication to receiving heparin or bivalirudin as a primary anticoagulant on ECMO

Study update

 

Study status:

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Screened:

Enrolled:

Starting up

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