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

Cardiac Arrest Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847482
• Other study ID #: COOL-ARREST JP
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: January 19, 2016

Study information

• Verified date: June 2014
• Source: ZOLL Circulation, Inc., USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 19, 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia

Intervention

Device:
• ZOLL Intravascular Temperature Management System (IVTM)
Induced therapeutic hypothermia post cardiac arrest

Locations

Country	Name	City	State
Japan	Nipponn Medical School Hospital	Bunkyo	Tokyo
Japan	Surugadai Nihon University Hospital	Chiyoda	Tokyo
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	National Hospital Organization Kumamoto Medical Center	Kumamoto
Japan	Kagawa University School of Medicine	Miki	Kagawa
Japan	Iwate Medical University Hospital	Morioka	Iwate
Japan	Hyogo College of Medicine Hospital	Nishinomiya	Hyogo
Japan	Osaka City General Hospital	Osaka
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaido
Japan	Yamaguchi University Hospital	Ube	Yamaguchi

Sponsors (2)

Lead Sponsor	Collaborator
ZOLL Circulation, Inc., USA	Asahi Kasei Medical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core temperature achievement ratio		Baseline and 3 hours
Secondary	Cerebral Performance Category (CPC)		Baseline and 14 days
Secondary	Modified Rankin Scale (mRS)		Baseline and 14 days
Secondary	Change in body temperature		Baseline and 96 hours
Secondary	Cooling speed		Baseline and 3 hours
Secondary	Safety	Incidence of adverse events at 2 days compared to baseline.	Baseline vs. 2 days
Secondary	Safety	Incidence of adverse events at 14 days compared to baseline.	Baseline vs. 14 days