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Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2

Study acronym: PRINCESS2
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial sites expanded: 11 → 17 locations
    • Eligibility criteria expanded, about 10 words
    • Publications: details revised at 2 of 2 entries
  2. Study sites: 8 to 11v6
  3. Site details revised at 1 of 8 sitesv5
  4. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Dec 2027 to Feb 2028
    • Study completion date: Mar 2028 to May 2028
    • Start date changed from estimate of Jan 2024 to Mar 27, 2024
    • Site details revised at 8 of 8 sites
  5. Re-verified, no change to tracked fieldsv3
  6. Primary completion date: Dec 2026 to Dec 2027v2 Show 4 more changesShow less
    • Start date: Oct 2023 to Jan 2024
    • Enrollment target: 970 to 1022
    • Study sites: 5 to 8
    • Study completion date: Mar 2027 to Mar 2028
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 aim of this clinical trial is to study the impact of ultra-early transnasal evaporative cooling after cardiac arrest and subsequent hypothermia at hospital, on survival with complete neurologic recovery, compared to currently recommended normothermia. The study population will consist of patients 18-79 years old, with out-of-hospital cardiac arrest with initial shockable rhythm. The main research question it aims to answer is whether there is a difference in survival with complete neurologic recovery at 90 days after cardiac arrest between the group of patients that received ultra-early cooling, compared to the group that was treated with normothermia. Participants will be randomized to two groups. One group (the intervention group) will receive ultra-early trans-nasal evaporative cooling initiated by EMS personnel at the scene of the cardiac arrest, and subsequent systemic hypothermia for 24 hours at hospital arrival. The other group (the control group), will receive standard of care (advanced cardiac life support and normal body temperature (normothermia)).
Trial Details
NCT Number NCT06025123
Lead Sponsor Karolinska Institutet
Conditions
(from sponsor)		 Out-Of-Hospital Cardiac Arrest, Hypothermia, Ventricular Fibrillation
Related terms Hypothermia, Out-of-Hospital Cardiac Arrest, Ventricular Fibrillation
Enrollment 1,022 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov