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โ† Trials
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Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest

RecruitingNAAges 18 Years - 75 YearsAllKagawa University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค32ยบC * 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Concomitant illness, such as malignancy, shortens life expectancy (180-day survival unlikely) * Consent not obtained or withdrawn by the participant or surrogate * Other reasons, physician's decision not to enroll the patient
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What it tests

  • Temperature control
  • Temperature control
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Where

29 sites
Kurume University Hospital
Kurume, Japan
Asahikawa Medical University Hospital
Asahikawa, Japan
Sapporo Medical University Hospital
Sapporo, Japan
Hokkaido University Hospital
Sapporo, Japan
Hyogo Prefectural Kakogawa Medical Center
Kakogawa, Japan
Hyogo Emergency Medical Center
Kobe, Japan
Toyooka Public Hospital
Toyooka, Japan
Hitachi General Hospital
Hitachi-shi, Japan

โ€ฆand 21 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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