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

ConditionsHeart FailureCardiogenic ShockCongenital Heart DiseaseCardiomyopathies
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age0-16
SponsorStanford University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cardiohelp device (VA-ECMO)

    Device

    The Cardiohelp system is a compact cardiopulmonary support system used off-label for ECMO for patients with cardiac and/or respiratory failure. It is currently FDA-cleared for \<6 hours of support for cardiopulmonary bypass.

  • Heparin

    Drug

    Blood thinner that works by inactivating factor Xa that is administered as a continuous intravenous infusion.

  • Bivalirudin

    Drug

    Blood thinner that works by inhibiting thrombin directly that is administered as a continuous intravenous infusion.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Cardiohelp device managed according to a standardized guideline using heparin anticoagulationExperimental treatment 2 interventions
Group B: Cardiohelp device managed according to a standardized guideline using bivalirudin anticoagulationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Survival to 30 days, recovery, ventricular assist device implant or transplant in the absence of severe symptomatic stroke (primary device effectiveness)

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.

Time frame
30 days of ECMO support or ECMO explant, whichever is earlier.
2

Symptomatic stroke (primary device safety)

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.

Time frame
30 days of ECMO support or ECMO explant, whichever is earlier.
3

Severe hemolysis (primary device safety)

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.

Time frame
30 days of ECMO support or ECMO explant, whichever is earlier.
4

Circuit change due to thrombus (primary device safety)

ECMO circuit change due primarily to thrombus that is probably or definitely related to the device.

Time frame
30 days of ECMO support or ECMO explant, whichever is earlier.

Secondary outcomes

1

Incidence of all serious adverse events

Incidence rate of all serious adverse events (per day of support)

Time frame
30 days
2

NHLBI bleeding and clotting score

The bleeding and clotting score as categorized by the ordinal 5-grade NHLBI score.

Time frame
through 30 days of ECMO support or ECMO explant, whichever is earlier.

Other outcomes

Sponsors and contacts

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Stanford University

Lead sponsor

Boston Children's Hospital

Collaborator

Duke University

Collaborator

FDA Office of Orphan Products Development

Collaborator

Source ClinicalTrials.gov
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