Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 11, 2013
June 30, 2014
March 2013
June 2014   (final data collection date for primary outcome measure)
Core temperature achievement ratio [ Time Frame: Baseline and 3 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01847482 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cardiac Arrest
Device: ZOLL Intravascular Temperature Management System (IVTM)
Induced therapeutic hypothermia post cardiac arrest
Experimental: Therapeutic Hypothermia
Intervention: Device: ZOLL Intravascular Temperature Management System (IVTM)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01847482
COOL-ARREST JP
Yes
ZOLL Circulation, Inc., USA
ZOLL Circulation, Inc., USA
Asahi Kasei Medical Co., Ltd.
Study Director: Yoichi Kato, PhD Asahi Kasei Medical Co., Ltd.
Principal Investigator: Tsuyoshi Maekawa, MD, PhD Yamaguchi Grand Medical Center
ZOLL Circulation, Inc., USA
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP