Clinical trial 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?
An investigational blood thinner being studied as a potential treatment for children with severe heart failure on ECMO support. It is designed to inactivate factor Xa (via antithrombin activation) to reduce blood clot formation.
Also referred to as unfractionated heparin.
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
- The study will see if the Cardiohelp ECMO device is safe and works well for kids with serious heart failure, and will compare heparin and bivalirudin to find which causes fewer bleeding or clot problems.
- Who it's for
- Children who have severe heart failure, cardiogenic shock, congenital heart disease, or cardiomyopathy and need ECMO support.
- What's involved
- Participants will receive the Cardiohelp VA‑ECMO support and be randomly assigned to either heparin or bivalirudin; doctors will collect data on survival, strokes, bleeding, and clotting.
- Time commitment
- Up to 30 days of ECMO support while in the hospital, with monitoring and data collection during that time.
- 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 2.5 to 80 kilograms
- VA-ECMO use for primary cardiac failure using the Cardiohelp system.
- First ECMO run during the current hospitalization
- Written informed consent from the parent or legally appointed representative (LAR)
You likely can't join if
- 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
See the full eligibility criteria
- Age 0 to 16 years of age (i.e., \<17 years)
- Body weight 2.5 to 80 kilograms
- VA-ECMO use for primary cardiac failure using the Cardiohelp system.
- First ECMO run during the current hospitalization
- Written informed consent from the parent or legally appointed representative (LAR)
- 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 is enrolling
- 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, but 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?
This study is enrolling now at 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 enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.