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RecruitingPhase 2

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

Multicenter Trial to Evaluate the Safety and Effectiveness of the Cardiohelp System for up to 30 Days of Support in Children With Severe Cardiac Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
0 Years to 16 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 30 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "This is a multicenter clinical trial to evaluate the safety and effectiveness of the Cardiohelp System for up to 30 days of support in children with severe cardiac failure."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe and effective the Cardiohelp heart-lung support machine is for up to 30 days in children with severe heart failure. It also compares two blood thinners, heparin and bivalirudin, to see which may cause fewer bleeding and clotting problems.

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 optimal performance specifications of the Cardiohelp device in children? The main questions the blood thinner randomized trial seeks to answer are: * Which blood thinner is more promising (i.e., more effective and safer) in children on the Cardiohelp device? * How should a pivotal trial of heparin vs. bivalirudin be designed so it is the most informative and efficient to determine the best blood thinner? Children who are receiving the Cardiohelp device will be approached and consented to participate if interested. For the Cardiohelp device trial, participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke, bleeding, and hemolysis. For the blood thinner randomized trial, participants will be randomized 1:1 to blood thinner strategy to determine which blood thinner has the fewest bleeding and clotting complications. For the Cardiohelp single-arm trial, participant outcomes will be compared to performance goals (PG) derived from the ECMO literature. For the blood thinner randomized trial, the amount of bleeding and clotting will be measured. The study is funded by an R01 grant from the FDA's Office of Orphan Product Development (OOPD).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Children ages 0 to 16 years.
  • Weigh 2.5 to 80 kilograms.
  • Use Cardiohelp VA-ECMO, a machine that supports the heart and lungs, mainly because of heart failure.
  • Be on their first ECMO treatment during this hospital stay.
  • Have written permission from a parent or legally appointed representative.

Who can't join

  • Age under 37 weeks after adjusting for being born early, or severe poor nutrition.
  • Bleeding or a blood-clotting problem that makes blood thinners unsafe; or an allergy or other reason they cannot receive heparin or bivalirudin.
  • Kidney, liver, or lung failure that cannot be reversed.
  • A stroke or unclear brain and nerve function within the past 30 days.
  • Use of an ECMO machine other than Cardiohelp, use of VV-ECMO (lung-only support), or ECMO mainly for lung failure.
  • Care focused only on comfort, or inability to come off the heart-lung bypass machine used during surgery.
  • Pregnant or breastfeeding.
  • For the blood thinner comparison only: cannot be assigned by chance to a treatment group within 30 hours after ECMO tubes are placed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (5)

CA

NC

NY

TX

WA