Cardiohelp ECMO support for children with severe cardiac failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter Phase 2 study combines a single-arm device evaluation of the Cardiohelp VA-ECMO system with a randomized comparison of heparin versus bivalirudin as primary anticoagulants in pediatric patients. The device component will collect safety and performance data during up to 30 days of support and compare outcomes to pre-specified pediatric performance benchmarks to inform FDA clearance decisions. The randomized drug component will compare circuit clotting and bleeding outcomes between unfractionated heparin and bivalirudin to inform planning of a pivotal Phase 3 anticoagulation trial. Participating centers include Stanford/Lucile Packard, Columbia/NYP, and Duke, and enrollment is limited to children meeting specific weight, age, and clinical stability criteria for VA-ECMO.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 0 to 16 years of age (i.e., \<17 years)
2. Body weight 2.5 to 80 kilograms
3. VA-ECMO use for primary cardiac failure using the Cardiohelp system.
4. First ECMO run during the current hospitalization
5. Written informed consent from the parent or legally appointed representative (LAR)

Exclusion Criteria:Children must not meet any of the following exclusion criteria after ECMO cannulation and immediately prior to consent:

1. Gestationally-corrected age \<37 weeks
2. Bleeding or coagulopathy that is a contraindication to anticoagulation
3. Irreversible renal, hepatic or lung failure
4. Stroke or uncertain neurological status within the past 30 days
5. Severely malnourished
6. Use of an ECMO system other than the Cardiohelp
7. VV-ECMO or ECMO for primary respiratory failure
8. Goals of patient to focus on comfort measures only.
9. Failure to separate from cardiopulmonary bypass
10. Allergy or contraindication to receiving UFH or bivalirudin as a primary anticoagulant on ECMO.
11. Patients who are pregnant or breastfeeding.
12. Unable to undergo randomization within 30 hours following ECMO cannulation (randomized cohort only)

Where it's running

• Lucile Packard Children's Hospital
  Palo Alto, California, United States Recruiting
• Cuimc/Nyph
  New York, New York, United States Recruiting
• Duke University Hospital
  Durham, North Carolina, United States Recruiting
• Children's Health Dallas
  Dallas, Texas, United States Recruiting
• Seattle Children's Hospital
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Lynn Sleeper, ScD — Boston Children's Hospital
• Study coordinator: Christopher SD Almond, MD, MPH
• Email: calmond@stanford.edu
• Phone: 6507237913

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.