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

This study has been completed.
Sponsor:
Collaborator:
Asahi Kasei Medical Co., Ltd.
Information provided by (Responsible Party):
ZOLL Circulation, Inc., USA
ClinicalTrials.gov Identifier:
NCT01847482
First received: February 11, 2013
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Cardiac Arrest
Device: ZOLL Intravascular Temperature Management System (IVTM)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by ZOLL Circulation, Inc., USA:

Primary Outcome Measures:
  • Core temperature achievement ratio [ Time Frame: Baseline and 3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cerebral Performance Category (CPC) [ Time Frame: Baseline and 14 days ] [ Designated as safety issue: No ]
  • Modified Rankin Scale (mRS) [ Time Frame: Baseline and 14 days ] [ Designated as safety issue: No ]
  • Change in body temperature [ Time Frame: Baseline and 96 hours ] [ Designated as safety issue: No ]
  • Cooling speed [ Time Frame: Baseline and 3 hours ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Baseline vs. 2 days ] [ Designated as safety issue: Yes ]
    Incidence of adverse events at 2 days compared to baseline.

  • Safety [ Time Frame: Baseline vs. 14 days ] [ Designated as safety issue: Yes ]
    Incidence of adverse events at 14 days compared to baseline.


Enrollment: 26
Study Start Date: March 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapeutic Hypothermia Device: ZOLL Intravascular Temperature Management System (IVTM)
Induced therapeutic hypothermia post cardiac arrest

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847482

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

No publications provided

Responsible Party: ZOLL Circulation, Inc., USA
ClinicalTrials.gov Identifier: NCT01847482     History of Changes
Other Study ID Numbers: COOL-ARREST JP
Study First Received: February 11, 2013
Last Updated: June 30, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by ZOLL Circulation, Inc., USA:
Cardiac arrest
Return of Spontaneous Circulation (ROSC)
IntraVascular Temperature Management (IVTM)
Therapeutic Hypothermia
Japan

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014