Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients in Japan

Inclusion criteria

• Non-traumatic in-hospital or out-of-hospital cardiac arrest
• Unwitnessed cardiac arrest (Ventricular fibrillation), or witnessed cardiac arrest (ventricular fibrillation, pulseless electrical activity, asystole within 15 minutes following onset)
• Patient is at least 20 years of age and less than 80 years of age with consent is given
• In the judgement of an investigator or sub-investigator, the patient is unable to follow verbal instructions
• Therapeutic hypothermia using the investigational device can be initiated within six hours of Return of Spontaneous Circulation (ROSC)
• Written consent can be obtained from a legally acceptable representative

Exclusion criteria

• Traumatic cardiac arrest (blunt trauma, penetrating trauma, burns, exsanguination, suffocation, smoke inhalation, near drowning, etc)
• Accidental hypothermia with core body temperature less than 35.0°C
• Pregnant or of child bearing potential
• Patient has given or indicated a Do Not Resuscitate (DNR) order
• Femoral venous access is contraindicated by previous surgey, medical history, anatomy or the like
• An inferior vena cava filter is in place
• Patient has severe bleeding (Pulmonary hemorrhage, gastrointestinal hemorrhage, etc.)
• Intracranial hemorrhage as confirmed by CT scanning
• Hemodynamic instability despite use of vasopressor agents and cardiac stimulants
• Heparin hypersensitivity
• Serious systemic infectious diseases (sepsis, etc.)
• Platelet count less than 30,000/mm3
• Serious hepatic dysfunction
• Serious renal impairment
• Using percutaneous cardiopulmonary support (PCPS)
• Using continuous hemodiafiltration (CHDF)
• Therapeutic hypothermia has been otherwise implemented between ROSC and the start of the study (excluding the rapid infusion of non-glucose-containing cold electrolyte fluid, or non-glucose-containing cold plasma volume expander)
• The patient's core body temperature cannot be monitored
• Currently participating in another clinical trial or has participated in another clinical trial within the past six months
• in the judgement of an investigator or sub-investigator, participation in this clinical trial is inappropriate for the patient