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

Study Overview
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Brief Summary
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A multicenter, single-arm, prospective, interventional trial to evaluate therapeutic hypothermia with intravascular temperature management (IVTM) in post-cardiogenic cardiac arrest, post-return of spontaneous circulation (ROSC) patients in Japan. The objective of this study is to verify that therapeutic hypothermia performed by intravascular cooling using the investigational device (IVTM) can control body temperature appropriately in post-cardiogenic cardiac arrest, post-ROSC patients.

Official Title
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COOL-ARREST JP: A Multicenter, Prospective, Single-arm Interventional Trial to Evaluate Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Device: ZOLL Intravascular Temperature Management System (IVTM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Hypothermia<br> | Device: ZOLL Intravascular Temperature Management System (IVTM)<br>* Induced therapeutic hypothermia post cardiac arrest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core temperature achievement ratio |  | Baseline and 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Performance Category (CPC) |  | Baseline and 14 days | 
| Modified Rankin Scale (mRS) |  | Baseline and 14 days | 
| Change in body temperature |  | Baseline and 96 hours | 
| Cooling speed |  | Baseline and 3 hours | 
| Safety | Incidence of adverse events at 2 days compared to baseline. | Baseline vs. 2 days | 
| Safety | Incidence of adverse events at 14 days compared to baseline. | Baseline vs. 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac arrest, Return of Spontaneous Circulation (ROSC), IntraVascular Temperature Management (IVTM), Therapeutic Hypothermia, Japan