Clinical trial NCT01847482: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Cardiac arrest
Return of Spontaneous Circulation (ROSC)
IntraVascular Temperature Management (IVTM)
Therapeutic Hypothermia
Japan
Lead sponsor: ZOLL Circulation, Inc., USA
Sponsor class: INDUSTRY
Collaborators: name: Asahi Kasei Medical Co., Ltd.
First posted: 2013-05-06
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Core temperature achievement ratio
timeFrame: Baseline and 3 hours
Secondary outcomes:
measure: Cerebral Performance Category (CPC)
timeFrame: Baseline and 14 days
measure: Modified Rankin Scale (mRS)
timeFrame: Baseline and 14 days
measure: Change in body temperature
timeFrame: Baseline and 96 hours
measure: Cooling speed
timeFrame: Baseline and 3 hours
measure: Safety
timeFrame: Baseline vs. 2 days
measure: Safety
timeFrame: Baseline vs. 14 days
Other outcomes:
Locations:
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine Hospital
state: Hyogo
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Miki
country: Japan
facility: Kagawa University School of Medicine
state: Kagawa
city: Bunkyo
country: Japan
facility: Nipponn Medical School Hospital
state: Tokyo
city: Chiyoda
country: Japan
facility: Surugadai Nihon University Hospital
state: Tokyo
city: Ube
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Osaka
country: Japan
facility: Osaka City General Hospital
Study officials:
affiliation: Asahi Kasei Medical Co., Ltd.
name: Yoichi Kato, PhD
role: STUDY_DIRECTOR
affiliation: Yamaguchi Grand Medical Center
name: Tsuyoshi Maekawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: