Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hos… (NCT06776549) | Clinical Trial Compass
RecruitingNot Applicable
Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest
Japan468 participantsStarted 2025-01-06
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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* Consent not obtained or withdrawn by the participant or surrogate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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing cooling the body (hypothermia) versus keeping it at normal temperature after ECMO is used to restart the heart — can you explain what we currently know about which approach tends to work better, and why there's still enough uncertainty that a trial like this is needed?
2Since this trial is listed as Phase NA and involves ECMO, which is already a very intensive life-support intervention, what does that mean for how much safety data exists on combining ECMO with deliberate cooling in out-of-hospital cardiac arrest survivors?
3The primary outcome being measured is survival — does that mean there's less information being collected about longer-term brain function or quality of life, and how might that affect our decision-making if survival alone isn't the only thing we care about?
4Given that ECMO itself is a complex procedure with serious risks, how would participating in this trial change the overall treatment plan compared to what would happen if we pursued standard care outside the trial?
5If a loved one had just experienced an out-of-hospital cardiac arrest and was already on ECMO, how quickly would a decision to enroll in this trial need to be made, and what happens if the family isn't ready to decide in that timeframe?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.