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Compares treatment options for Out-of-hospital Cardiac Arrest (OHCA)
Official title Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest
ClinicalTrials.gov ID: NCT06776549
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- OHCA
- Age of 18-75 years, known or estimated
- An initial cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia or pulseless electrical activity
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kurume, Fukuoka, Japan
- Asahikawa, Hokkaido, Japan
- Sapporo, Hokkaido, Japan
- Kakogawa, Hyōgo, Japan
- Kobe, Hyōgo, Japan
- Toyooka, Hyōgo, Japan
- Kita-gun, Kagawa-ken, Japan
- Amami, Kagoshima-ken, Japan
- Ebina, Kanagawa, Japan
- Yokohama, Kanagawa, Japan
- Kyoto, Kyoto, Japan
- Sendai, Miyagi, Japan
- Okayama, Okayama-ken, Japan
- Tsuyama, Okayama-ken, Japan
- Shimajiri-gun, Okinawa, Japan
- Suita, Osaka, Japan
- Saitama, Saitama, Japan
- Tottori-shi, Tottori, Japan
- Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kurume, Fukuoka, Japan; Asahikawa, Hokkaido, Japan; Sapporo, Hokkaido, Japan; Kakogawa, Hyōgo, Japan; Kobe, Hyōgo, Japan; Toyooka, Hyōgo, Japan and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.