Intravenous Vs. Intraosseous Vascular Access During Out-of-Hospital

Study acronym: IVIO
StatusUnknown
PhasePhase 4
Started

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Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Study sites: 4 to 5
    • Study completion date: Feb 28, 2025 to May 5, 2025
    v7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1262 to confirmed 1479
    • Primary completion date changed from estimate of Feb 28, 2024 to May 5, 2024
    • Site details revised at 4 of 4 sites
    v6
  4. Site details revised at 1 of 4 sitesv5
  5. Enrollment target: 762 to 1262
    • Study sites: 1 to 4
    v4
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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 "Intravenous vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest (IVIO)"-trial is an investigator-initiated, randomized, parallel group, patient and outcome assessor-blinded, superiority trial of intravenous vs. intraosseous vascular access during adult out-of-hospital cardiac arrest. The intraosseous group will be further randomized to humeral vs. tibial access. The trial will be conducted in the Central Denmark Region. The primary outcome will be sustained return of spontaneous circulation, and 762 patients will be included. Key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.
Trial Details
NCT Number NCT05205031
Lead Sponsor Lars Wiuff Andersen
Collaborators: Central Denmark Region, University of Aarhus
Conditions
(from sponsor)		 Cardiac Arrest
Related terms Heart Arrest
Enrollment 1,479 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov