NCT06776549 Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest
| NCT ID | NCT06776549 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kagawa University |
| Condition | Out-of-hospital Cardiac Arrest (OHCA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 468 participants |
| Start Date | 2025-01-06 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 468 participants in total. It began in 2025-01-06 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The SAVE-J NEUROTHERM trial is a cluster randomized trial that evaluated and compared the mortality risk, neurological outcomes, and adverse events between patients who underwent hypothermia and those who underwent normothermia after extracorporeal cardiopulmonary resuscitation for out-of-hospital cardiac arrest.
Eligibility Criteria
Inclusion Criteria: * OHCA * Age of 18-75 years, known or estimated * An initial cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia or pulseless electrical activity Exclusion Criteria: * ECMO initiated after sustained return of spontaneous circulation (ROSC) and patients with sustained ROSC before ECMO initiation * OHCA of presumed non-cardiac etiology * Time from emergency call or witnessed arrest to hospital arrival of \>60 min * Time from hospital arrival to ECMO initiation of \>60 min * Pre-hospital ECPR * Unavailability of the ECMO heat exchanger for temperature control * Glasgow Coma Scale score before temperature control of \>8 * Core body temperature upon hospital arrival of ≤32ºC * Surgical intervention before temperature control (e.g., surgical intervention for the primary disease or complications related to resuscitation/ECMO procedures) * Do Not Attempt Resuscitation) order confirmed prior to temperature control * Limitations in intensive care before temperature control * Known cerebral performance category (CPC) of 3-4 before cardiac arrest * Known chronic obstructive pulmonary disease with home oxygen therapy * Known or suspected pregnancy * Concomitant illness, such as malignancy, shortens life expectancy (180-day survival unlikely) * Consent not obtained or withdrawn by the participant or surrogate * Other reasons, physician's decision not to enroll the patient
Contact & Investigator
Akihiko Inoue
PRINCIPAL INVESTIGATOR
Hyogo Emergency Medical Center
Frequently Asked Questions
Who can join the NCT06776549 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Out-of-hospital Cardiac Arrest (OHCA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06776549 currently recruiting?
Yes, NCT06776549 is actively recruiting participants. Contact the research team at j-neuro@googlegroups.com for enrollment information.
Where is the NCT06776549 trial being conducted?
This trial is being conducted at Kurume, Japan, Asahikawa, Japan, Sapporo, Japan, Sapporo, Japan and 11 additional locations.
Who is sponsoring the NCT06776549 clinical trial?
NCT06776549 is sponsored by Kagawa University. The principal investigator is Akihiko Inoue at Hyogo Emergency Medical Center. The trial plans to enroll 468 participants.