Eligibility

Inclusion criteria

  • Age 0 to 16 years
  • Body weight of 2.5-80 kilograms
  • VA-ECMO use for primary cardiac failure using the Cardiohelp system
  • First ECMO run during the current hospitalization

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
  • Patients who are known to be pregnant or breastfeeding
  • Unable to undergo randomization within 30 hours following ECMO cannulation (randomized cohort only)

Study update

 

Study status:

Sites:

Target enrollment:

Screened:

Enrolled:

Enrolling

6

50

211

28