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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Device: ZOLL Intravascular Temperature Management System (IVTM)

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Kumamoto, Japan, 860-0008
    • National Hospital Organization Kumamoto Medical Center
  • Osaka, Japan, 534-0021
    • Osaka City General Hospital
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 802-8555
      • Kokura Memorial Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8543
      • Sapporo Medical University Hospital
  • Hyogo
    • Nishinomiya, Hyogo, Japan, 663-8501
      • Hyogo College of Medicine Hospital
  • Iwate
    • Morioka, Iwate, Japan, 020-8505
      • Iwate Medical University Hospital
  • Kagawa
    • Miki, Kagawa, Japan, 761-0793
      • Kagawa University School of Medicine
  • Tokyo
    • Bunkyo, Tokyo, Japan, 113-8603
      • Nipponn Medical School Hospital
    • Chiyoda, Tokyo, Japan, 101-8309
      • Surugadai Nihon university hospital
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-8505
      • Yamaguchi University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapeutic Hypothermia	Device: ZOLL Intravascular Temperature Management System (IVTM); Induced therapeutic hypothermia post cardiac arrest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: ZOLL Circulation, Inc., USA
• Collaborators: Asahi Kasei Medical Co., Ltd.
• Investigators: Study Director: Yoichi Kato, PhD, Asahi Kasei Medical Co., Ltd.; Principal Investigator: Tsuyoshi Maekawa, MD, PhD, Yamaguchi Grand Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): January 19, 2016

Study Registration Dates

• First Submitted: February 11, 2013
• First Submitted That Met QC Criteria: May 1, 2013
• First Posted (Estimate): May 6, 2013

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Cardiac arrest; Japan; Therapeutic Hypothermia; Return of Spontaneous Circulation (ROSC); IntraVascular Temperature Management (IVTM)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Heart Arrest; Hypothermia
• Other Study ID Numbers: COOL-ARREST JP