Actively Recruiting
Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest
Led by Kagawa University · Updated on 2025-06-27
468
Participants Needed
28
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Out-of-hospital cardiac arrest (OHCA)
- Age between 18 and 75 years, known or estimated
- Initial cardiac arrest rhythm of ventricular fibrillation, pulseless ventricular tachycardia, or pulseless electrical activity
You will not qualify if you...
- ECMO started after sustained return of spontaneous circulation (ROSC) or presence of sustained ROSC before ECMO
- OHCA due to presumed non-cardiac cause
- Time from emergency call or witnessed arrest to hospital arrival over 60 minutes
- Time from hospital arrival to ECMO initiation over 60 minutes
- Pre-hospital ECPR
- Unavailability of ECMO heat exchanger for temperature control
- Glasgow Coma Scale score before temperature control greater than 8
- Core body temperature upon hospital arrival 32 0C or lower
- Surgical intervention before temperature control
- Do Not Attempt Resuscitation order confirmed before temperature control
- Limitations in intensive care before temperature control
- Known cerebral performance category of 3 to 4 before cardiac arrest
- Known chronic obstructive pulmonary disease with home oxygen therapy
- Known or suspected pregnancy
- Concomitant illness shortening life expectancy (less than 180-day survival likely)
- Consent not obtained or withdrawn
- Other physician decisions not to enroll patient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Kurume University Hospital
Kurume, Fukuoka, Japan, 8300011
Actively Recruiting
2
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan, 0788510
Not Yet Recruiting
3
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan, 0608556
Actively Recruiting
4
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 0608648
Actively Recruiting
5
Hyogo Prefectural Kakogawa Medical Center
Kakogawa, Hyōgo, Japan, 6758555
Actively Recruiting
6
Hyogo Emergency Medical Center
Kobe, Hyōgo, Japan, 6510073
Actively Recruiting
7
Toyooka Public Hospital
Toyooka, Hyōgo, Japan, 6688501
Actively Recruiting
8
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan, 7610793
Actively Recruiting
9
Oshima Prefectural Hospital
Amami, Kagoshima-ken, Japan, 8940015
Actively Recruiting
10
Ebina General Hospital
Ebina, Kanagawa, Japan, 2430432
Actively Recruiting
11
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, Japan, 2308765
Actively Recruiting
12
Kyoto Second Red Cross Hospital
Kyoto, Kyoto, Japan, 6028026
Not Yet Recruiting
13
Tohoku University Hospital
Sendai, Miyagi, Japan, 9808574
Actively Recruiting
14
Sendai Medical Center
Sendai, Miyagi, Japan, 9838520
Actively Recruiting
15
Okayama University Hospital
Okayama, Okayama-ken, Japan, 7008558
Actively Recruiting
16
Tsuyama Chuo Hospital
Tsuyama, Okayama-ken, Japan, 7080841
Actively Recruiting
17
Okinawa Prefectural Nanbu Medical Center & Children's Medical Center
Shimajiri-gun, Okinawa, Japan, 9011193
Actively Recruiting
18
Osaka Saiseikai Senri Hospital
Suita, Osaka, Japan, 5650862
Actively Recruiting
19
Saitama Red Cross Hospital
Saitama, Saitama, Japan, 3308553
Actively Recruiting
20
Tottori Prefectural Central Hospital
Tottori-shi, Tottori, Japan, 6800901
Actively Recruiting
21
St. Luke's International Hospital
Tokyo, Japan, 1048560
Actively Recruiting
22
Institute of Science Tokyo Hospital
Tokyo, Japan, 1138519
Actively Recruiting
23
Nippon Medical School Hospital
Tokyo, Japan, 1138603
Actively Recruiting
24
Tokyo Metropolitan Bokutoh Hospital
Tokyo, Japan, 1308575
Actively Recruiting
25
Keio University Hospital
Tokyo, Japan, 1608582
Actively Recruiting
26
Japanese Red Cross Musashino Hospital
Tokyo, Japan, 1808610
Actively Recruiting
27
Tokyo Metropolitan Tama Medical Center
Tokyo, Japan, 1838524
Actively Recruiting
28
National Hospital Organization Disaster Medical Center
Tokyo, Japan, 1900014
Actively Recruiting
Research Team
A
Akihiko Inoue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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