Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest

Recruiting now · Not applicable

Conditions studied: Out-of-hospital Cardiac Arrest (OHCA), ECMO Treatment, Temperature, Post Cardiac Arrest Syndrome

In brief

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.

Key facts

Study ID

NCT06776549

Run by

Kagawa University

People needed

468

Starts

2025-01-06

Expected to finish

2030-01-31

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 may not qualify 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
• 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• Consent not obtained or withdrawn by the participant or surrogate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

Where it is running

• National Hospital Organization Disaster Medical Center — Tokyo, Japan (enrolling)
• Tokyo Metropolitan Tama Medical Center — Tokyo, Japan (enrolling)
• Kurume University Hospital — Kurume, Fukuoka, Japan (enrolling)
• Sapporo Medical University Hospital — Sapporo, Hokkaido, Japan (enrolling)
• Hokkaido University Hospital — Sapporo, Hokkaido, Japan (enrolling)
• Hyogo Prefectural Kakogawa Medical Center — Kakogawa, Hyōgo, Japan (enrolling)
• Hyogo Emergency Medical Center — Kobe, Hyōgo, Japan (enrolling)
• Toyooka Public Hospital — Toyooka, Hyōgo, Japan (enrolling)
• Hitachi General Hospital — Hitachi-shi, Ibaraki, Japan (enrolling)
• Kagawa University Hospital — Kita-gun, Kagawa-ken, Japan (enrolling)
• Oshima Prefectural Hospital — Amami, Kagoshima-ken, Japan (enrolling)
• Ebina General Hospital — Ebina, Kanagawa, Japan (enrolling)
• Saiseikai Yokohamashi Tobu Hospital — Yokohama, Kanagawa, Japan (enrolling)
• Tohoku University Hospital — Sendai, Miyagi, Japan (enrolling)
• Sendai Medical Center — Sendai, Miyagi, Japan (enrolling)
• Okayama University Hospital — Okayama, Okayama-ken, Japan (enrolling)
• Tsuyama Chuo Hospital — Tsuyama, Okayama-ken, Japan (enrolling)
• Okinawa Prefectural Nanbu Medical Center & Children's Medical Center — Shimajiri-gun, Okinawa, Japan (enrolling)
• Osaka Saiseikai Senri Hospital — Suita, Osaka, Japan (enrolling)
• Saitama Red Cross Hospital — Saitama, Saitama, Japan (enrolling)
• Tottori Prefectural Central Hospital — Tottori-shi, Tottori, Japan (enrolling)
• St. Luke's International Hospital — Tokyo, Japan (enrolling)
• Institute of Science Tokyo Hospital — Tokyo, Japan (enrolling)
• Nippon Medical School Hospital — Tokyo, Japan (enrolling)
• Tokyo Metropolitan Bokutoh Hospital — Tokyo, Japan (enrolling)

Full record on ClinicalTrials.gov

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