Acute Brain InjuryNCT06469801
ECMO ABI Detection With Hyperfine
A study testing Hyperfine in people with Acute Brain Injury and Extracorporeal Membrane Oxygenation Complication, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The primary objective is to characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support. The secondary objective is to describe the time course and rates of ABI using ultralow-field bedside MRI relative to both duration of ECMO support and clinical imaging obtained… Read more about this study
- Who is it for?
- Ages 0 days to 17 years
- Conditions the study is for
- Acute Brain Injury, Extracorporeal Membrane Oxygenation Complication, Hypoxia-Ischemia, Brain
- What is being tested?
- Hyperfine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to 1 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants that will be or are admitted to the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit
- Ages 0-17 years
- Participants that are at high risk for undergoing ECMO or are currently undergoing venovenous or venoarterial ECMO
- High risk participants include, but are not limited to:
- Undergoing cardiac surgery
- Congenital heart disease
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- Congenital diaphragmatic hernia
- Refractory hypoxemic and/or hypercarbic respiratory failure
- Vasoactive-refractory shock
Who cannot join
- Pregnancy
- Any patient who has a contraindication to having an MRI
- Patients with a passive or active implant will:
- First be reviewed on MRISafety.com to determine MR conditionality
- If device is listed as Conditional or Unsafe for a 1.5T or a 3T, device will then be reviewed by MRI Safety Officer or MRI Physician Section chief to determine true conditionality for the portable MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Mercy
Kansas City, Missouri, 64108
Maura Sien, RT(R), CCRC, mesien@cmh.edu
Jessica Wallisch, MD, jwallisch@cmh.edu
About this study
Official title: Low-Field Bedside MRI for Detection of Acute Brain Injury in Pediatric Extracorporeal Membrane Oxygenation
The primary objective is to characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support. The secondary objective is to describe the time course and rates of ABI using ultralow-field bedside MRI relative to both duration of ECMO support and clinical imaging obtained in routine care of pediatric ECMO patients.
Read the detailed description
Extracorporeal membrane oxygenation (ECMO) is frequently used to treat refractory cardiovascular and/or respiratory failure. As the support modality has evolved, survival has significantly improved, yet there are high rates of acute brain injury (ABI) in this population due to disease, patient, and treatment factors. This results in significant morbidity and mortality. Specifically, thromboembolic, hypoxic-ischemic, and hemorrhagic complications occur during ECMO support, but the investigators are limited in the monitoring and diagnosis of ABI while on ECMO as currently available imaging modalities (i.e. ultrasound [US], computed tomography [CT]) have low sensitivity for early hypoxic, cerebrovascular, and ischemic brain injuries. The sensitivity of these modalities increases only when it is too late to effectively intervene. Standard magnetic resonance imaging (MRI) is the gold standard to diagnose stroke and ischemic brain injury but is incompatible with ECMO devices. Swoop (Hyperfine, Guilford, CT) is an FDA cleared ultralow-field portable MRI system that can be used at the bedside and has been studied in critically ill adults with various types of ABI. This novel bedside MRI has been safely operated in clinical environments with equipment that is typically not MRI compatible. A few adult and pediatric ECMO patients have undergone bedside brain MRIs showing feasibility. Yet, what remains unknown is the true prevalence and timing of hypoxic, cerebrovascular, and ischemic brain injuries in pediatric ECMO.
- Conditions
- Acute Brain Injury, Extracorporeal Membrane Oxygenation Complication, Hypoxia-Ischemia, Brain, Stroke, Acute
- Being tested
- Hyperfine
- Keywords
- Pediatric
- Medical subject headings
- Brain Injuries, Hypoxia-Ischemia, Brain, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperfineDevice
Enrolled subjects will undergo a Hyperfine MRI exam, which is a portable, low-field MRI, at various timepoints during their clinical course on ECMO. Patients will undergo imaging within 36 hours of ECMO initiation/cannulation. Patients that remain on ECMO will have repeat imaging at 72-120 hours of ECMO therapy and again weekly for the duration of their ECMO course. Patients may also undergo a portable MRI within 24 hours of clinical head imaging, if applicable.
| Study group | Role | What they receive |
|---|---|---|
| Portable MRI Arm | Experimental | All subjects enrolled will be assigned to Arm 1 Receives: Device: Hyperfine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support.
Perform bedside MRI in pediatric ECMO patients treated in pediatric, cardiac, and neonatal intensive care units (ICUs) within 36 hours of cannulation. Determine rates of ABI (hypoxic, ischemic, cerebrovascular, and hemorrhagic injury along with assessment of cerebral edema and midline shift) in the pre- and peri-cannulation time periods. Correlate these imaging findings to rates of clinical neurological events (seizures, pupillary changes, focal neurological examination).
Measured: Duration of ECMO treatment period, an average of <2 weeks
Describe the time course and rates of ABI using ultralow-field bedside MRI relative to both duration of ECMO support and clinical imaging obtained in routine care of pediatric ECMO patients.
Obtain bedside MRI in pediatric ECMO patients treated in pediatric, cardiac or neonatal ICUs at 72-120 hours post-cannulation and weekly until decannulation. Quantify and compare rates of ABI between bedside MRI and CT or US as read by blinded neuroradiologist.
Measured: Duration of ECMO treatment period, an average of <2 weeks
Secondary outcomes (1)
Assess the association of clinical neurologic events to presence and type of imaging findings.
Rates of seizures, pupillary changes, focal neurologic deficits, and neuromonitoring data will be correlated to neuroimaging diagnoses of acute brain injury.
Measured: From ICU admission to final neuroimaging during active study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start23 Jul 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica S. Wallisch, Children's Mercy Hospital Kansas City
- Investigators
- Jessica Wallisch, MD, Principal investigator, Children's Mercy Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469801
- Sponsor's protocol ID
- STUDY00003208
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is reasonable concern that sharing of IPD could allow patient re-identification given the single center study design involving a small and unique patient cohort. Given consideration for patient privacy, IPD will not be shared on open data platforms. De-identified IPD is available at reasonable request to the study PI with IRB approval and appropriate contracting.