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

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
ZOLL Intravascular Temperature Management System (IVTM)
Sponsored by
ZOLL Circulation, Inc., USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Cardiac arrest, Return of Spontaneous Circulation (ROSC), IntraVascular Temperature Management (IVTM), Therapeutic Hypothermia, Japan

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Traumatic cardiac arrest (blunt trauma, penetrating trauma, burns, exsanguination, suffocation, smoke inhalation, near drowning, etc)
  2. Accidental hypothermia with core body temperature less than 35.0°C
  3. Pregnant or of child bearing potential
  4. Patient has given or indicated a Do Not Resuscitate (DNR) order
  5. Femoral venous access is contraindicated by previous surgey, medical history, anatomy or the like
  6. An inferior vena cava filter is in place
  7. Patient has severe bleeding (Pulmonary hemorrhage, gastrointestinal hemorrhage, etc.)
  8. Intracranial hemorrhage as confirmed by CT scanning
  9. Hemodynamic instability despite use of vasopressor agents and cardiac stimulants
  10. Heparin hypersensitivity
  11. Serious systemic infectious diseases (sepsis, etc.)
  12. Platelet count less than 30,000/mm3
  13. Serious hepatic dysfunction
  14. Serious renal impairment
  15. Using percutaneous cardiopulmonary support (PCPS)
  16. Using continuous hemodiafiltration (CHDF)
  17. 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)
  18. The patient's core body temperature cannot be monitored
  19. Currently participating in another clinical trial or has participated in another clinical trial within the past six months
  20. in the judgement of an investigator or sub-investigator, participation in this clinical trial is inappropriate for the patient

Sites / Locations

  • Kokura Memorial Hospital
  • Sapporo Medical University Hospital
  • Hyogo College of Medicine Hospital
  • Iwate Medical University Hospital
  • Kagawa University School of Medicine
  • Nipponn Medical School Hospital
  • Surugadai Nihon University Hospital
  • Yamaguchi University Hospital
  • National Hospital Organization Kumamoto Medical Center
  • Osaka City General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapeutic Hypothermia

Arm Description

Outcomes

Primary Outcome Measures

Core temperature achievement ratio

Secondary Outcome Measures

Cerebral Performance Category (CPC)
Modified Rankin Scale (mRS)
Change in body temperature
Cooling speed
Safety
Incidence of adverse events at 2 days compared to baseline.
Safety
Incidence of adverse events at 14 days compared to baseline.

Full Information

First Posted
February 11, 2013
Last Updated
June 25, 2018
Sponsor
ZOLL Circulation, Inc., USA
Collaborators
Asahi Kasei Medical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01847482
Brief Title
Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients in Japan
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
January 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZOLL Circulation, Inc., USA
Collaborators
Asahi Kasei Medical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Cardiac arrest, Return of Spontaneous Circulation (ROSC), IntraVascular Temperature Management (IVTM), Therapeutic Hypothermia, Japan

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Hypothermia
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ZOLL Intravascular Temperature Management System (IVTM)
Intervention Description
Induced therapeutic hypothermia post cardiac arrest
Primary Outcome Measure Information:
Title
Core temperature achievement ratio
Time Frame
Baseline and 3 hours
Secondary Outcome Measure Information:
Title
Cerebral Performance Category (CPC)
Time Frame
Baseline and 14 days
Title
Modified Rankin Scale (mRS)
Time Frame
Baseline and 14 days
Title
Change in body temperature
Time Frame
Baseline and 96 hours
Title
Cooling speed
Time Frame
Baseline and 3 hours
Title
Safety
Description
Incidence of adverse events at 2 days compared to baseline.
Time Frame
Baseline vs. 2 days
Title
Safety
Description
Incidence of adverse events at 14 days compared to baseline.
Time Frame
Baseline vs. 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoichi Kato, PhD
Organizational Affiliation
Asahi Kasei Medical Co., Ltd.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tsuyoshi Maekawa, MD, PhD
Organizational Affiliation
Yamaguchi Grand Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Hyogo College of Medicine Hospital
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Kagawa University School of Medicine
City
Miki
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Nipponn Medical School Hospital
City
Bunkyo
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Surugadai Nihon University Hospital
City
Chiyoda
State/Province
Tokyo
ZIP/Postal Code
101-8309
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Facility Name
Osaka City General Hospital
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan

12. IPD Sharing Statement

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

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