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ECMO ABI Detection With Hyperfine

StatusRecruiting
PhaseNot applicable
Started
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Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
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Record History

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  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Lead sponsor: Children's Mercy Hospital Kansas City to Children's Mercy Hospital Kansas City
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoint revised
    • Study description revised
    • Site details revised
  2. Enrollment increased: 30 → 40 participants
    • Eligibility criteria expanded, about 2 words
    v7
  3. Primary completion date: Jun 30, 2026 to Jun 30, 2027
    • Study completion date: Jul 1, 2026 to Dec 1, 2027
    v6
  4. Study Identification, Study Status, Sponsor/Collaborators, Oversight, Arms and Interventions, Outcome Measuresv5
  5. Eligibility criteria expanded, about 44 wordsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 1, 2024 to Jul 23, 2024
    v3
  2. Start date: Jul 1, 2024 to Aug 1, 2024
    • Study description expanded, about 1 word
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06469801
Lead Sponsor Children's Mercy Hospital Kansas City
Conditions
(from sponsor)		 Acute Brain Injury, Extracorporeal Membrane Oxygenation Complication, Hypoxia-Ischemia, Brain, Stroke, Acute
Related terms Brain Injuries, Hypoxia-Ischemia, Brain, Stroke
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov