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Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System

RecruitingPhase 2Ages 0 Years - 16 YearsAllStanford University
NCT06080074 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to: 1. To evaluate the safety and effectiveness of the Cardiohelp Device for VA-ECMO (heart-lung support) for up to 30 days of support in children with severe heart failure with the goal to support its FDA clearance in children. 2. To evaluate heparin versus bivalirudin as the primary blood thinner (anticoagulant) in a randomized trial of children supported with the Cardiohelp ECMO System with the goal to plan a phase III (pivotal) randomized clinical trial The main questions the Cardiohelp single-arm trial seeks to answer are: * What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO? * Should the Cardiohelp device be FDA-cleared for children based on the results of the study? * What are the o

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📋 Eligibility rules (as published)
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)
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What it tests

  • Cardiohelp device (VA-ECMO)
  • Heparin
  • Bivalirudin
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Where

5 sites
Lucile Packard Children's Hospital
Palo Alto, United States
Cuimc/Nyph
New York, United States
Duke University Hospital
Durham, United States
Children's Health Dallas
Dallas, United States
Seattle Children's Hospital
Seattle, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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