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New treatment option for Heart Failure
Official title Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
ClinicalTrials.gov ID: NCT06080074
What this study is testing
What is Heparin?
Heparin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 16
You may be able to join if
- Age 0 to 16 years of age (i.e., \<17 years)
- Body weight 3 to 80 kilograms
- VA-ECMO use for primary cardiac failure using the Cardiohelp system.
- First ECMO run during the current hospitalization
You likely can't join if
- Children must not meet any of the following exclusion criteria within 48 hours prior to device implant:
- 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
See the full eligibility criteria
- Age 0 to 16 years of age (i.e., \<17 years)
- Body weight 3 to 80 kilograms
- VA-ECMO use for primary cardiac failure using the Cardiohelp system.
- First ECMO run during the current hospitalization
- Children must not meet any of the following exclusion criteria within 48 hours prior to device implant:
- 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 UFH or bivalirudin as a primary anticoagulant on ECMO.
- Patients who are pregnant or breastfeeding.
- Unable to undergo randomization within 30 hours following ECMO cannulation (assigned by chance cohort only)
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 16 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; New York, New York, United States; Durham, North Carolina, United States; Dallas, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.