Cardiohelp System for Children with Severe Heart Failure
This study is testing a device called Cardiohelp for children aged 0-16 years (weighing 3-80 kg) who have severe heart failure and need support for their heart and lungs (VA-ECMO). Currently, all ECMO use in children is considered "off-label" because no standalone device has specific FDA approval for pediatric use. This trial aims to gather information to help the Cardiohelp device get FDA clearance for up to 30 days of use in children. The study is also comparing two blood thinners, heparin and bivalirudin, to see which works best to prevent blood clots while on the Cardiohelp system. We are looking for 50 participants. The main goals are to see if the Cardiohelp device helps children survive and recover, and to check for serious side effects like stroke or severe red blood cell damage.
- Study design
- This is a multicenter clinical trial with 50 participants. It combines a study of the Cardiohelp device with a randomized comparison of two blood thinners, heparin and bivalirudin.
- What's involved
- Participants will receive VA-ECMO support using the Cardiohelp system for up to 30 days. They will also be given either heparin or bivalirudin as a continuous intravenous infusion.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and effectiveness will be measured at 30 days of ECMO support or when ECMO is removed, whichever comes first.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
At a glance
Conditions
Where it's being run
5 sites across 5 statesStudy leadership
- Lynn Sleeper, ScD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital
- Caroline Ozment, MD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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What this trial measures
- Survival to 30 days, recovery, ventricular assist device implant or transplant in the absence of severe symptomatic stroke (primary device effectiveness)30 days of ECMO support or ECMO explant, whichever is earlier.
Survival in the absence of severe symptomatic stroke to 30 days or decannulation for recovery, transplant or VAD implant. For patients with stroke definitely or probably related to ECMO, symptoms and severity will be determined at hospital discharge or 90 days, whichever is first.
- Symptomatic stroke (primary device safety)30 days of ECMO support or ECMO explant, whichever is earlier.
For patients with stroke definitely or probably related to ECMO, the presence of stroke symptoms and its severity will be determined at hospital discharge or 90 days, whichever is first.
- Severe hemolysis (primary device safety)30 days of ECMO support or ECMO explant, whichever is earlier.
Severe hemolysis as defined by the plasma-free hemoglobin level \>100 mg/dL confirmed on repeat testing and outside the first 72 hours that is probably or definitely related to the device.
- Circuit change due to thrombus (primary device safety)30 days of ECMO support or ECMO explant, whichever is earlier.
ECMO circuit change due primarily to thrombus that is probably or definitely related to the device.
- Circuit change due primarily to device malfunction (primary device safety)30 days of ECMO support or ECMO explant, whichever is earlier.
Circuit change due primarily to device malfunction that is probably or definitely related to the device.
- Renal injury/failure (primary device safety)30 days of ECMO support or ECMO explant, whichever is earlier.
renal injury/failure defined as three times the upper limit of normal or 3X baseline if the baseline is above the upper limit of normal.
- Circuit-change free survival primarily due to thrombus (primary safety endpoint for anticoagulation RCT)30 days of ECMO support or ECMO explant, whichever is earlier.
Circuit-change free survival where the circuit is change is primarily due to thrombus and is definitely or probably related to the anticoagulant (primary safety endpoint for anticoagulation RCT)
- Bleeding30 days of ECMO support or ECMO explant, whichever is earlier.
Total red blood cell transfusion volume in cc/kg/day probably or definitely related to the anticoagulant.