Phase 2 Cardiomyopathy Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- The child is between 0 and 16 years old (under 17 years)
- The child weighs between 3 and 80 kilograms
- The child is using a specific type of heart-lung bypass machine called the Cardiohelp system, to support a failing heart (VA-ECMO)
- This is the child's first time on this type of bypass machine during their current hospital stay
Who may not be able to join:
- The child was born prematurely and their corrected age is still under 37 weeks
- The child has a bleeding disorder or blood clotting problem that makes blood-thinning medication unsafe to use
- The child has permanent, irreversible failure of the kidneys, liver, or lungs
- The child has had a stroke, or their brain/neurological condition is uncertain, within the past 30 days
- The child is severely malnourished
- The child is using a different heart-lung bypass machine other than the Cardiohelp system
- The child is on a type of bypass support meant for lung problems rather than heart problems (VV-ECMO or ECMO for breathing failure)
- The child's care goals are focused on comfort care only, rather than active treatment
- The child was unable to be taken off the heart-lung bypass machine used during heart surgery
- The child has an allergy or medical reason they cannot receive specific blood-thinning medications (UFH or bivalirudin) while on the bypass machine
- The child is pregnant or breastfeeding
- For one part of the study: the child cannot be enrolled into the random assignment process within 30 hours of being connected to the bypass machine (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Lynn Sleeper, ScD, Boston Children's Hospital
Phone: 6507237913
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Survival to 30 days, recovery, ventricular assist device implant or transplant in the absence of severe symptomatic stroke (primary device effectiveness); Symptomatic stroke (primary device safety); Severe hemolysis (primary device safety); Circuit change due to thrombus (primary device safety); Circuit change due primarily to device malfunction (primary device safety); Renal injury/failure (primary device safety); Circuit-change free survival primarily due to thrombus (primary safety endpoint for anticoagulation RCT); Bleeding
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.