Status:
COMPLETED
Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients in Japan
Lead Sponsor:
ZOLL Circulation, Inc., USA
Collaborating Sponsors:
Asahi Kasei Medical Co., Ltd.
Conditions:
Cardiac Arrest
Eligibility:
All Genders
20-80 years
Phase:
NA
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 spo...
Eligibility Criteria
Inclusion
- Non-traumatic in-hospital or out-of-hospital cardiac arrest
- Unwitnessed cardiac arrest (Ventricular fibrillation), or witnessed cardiac arrest (ventricular fibrillation, pulseless electrical activity, asystole within 15 minutes following onset)
- Patient is at least 20 years of age and less than 80 years of age with consent is given
- In the judgement of an investigator or sub-investigator, the patient is unable to follow verbal instructions
- Therapeutic hypothermia using the investigational device can be initiated within six hours of Return of Spontaneous Circulation (ROSC)
- Written consent can be obtained from a legally acceptable representative
Exclusion
- Traumatic cardiac arrest (blunt trauma, penetrating trauma, burns, exsanguination, suffocation, smoke inhalation, near drowning, etc)
- Accidental hypothermia with core body temperature less than 35.0°C
- Pregnant or of child bearing potential
- Patient has given or indicated a Do Not Resuscitate (DNR) order
- Femoral venous access is contraindicated by previous surgey, medical history, anatomy or the like
- An inferior vena cava filter is in place
- Patient has severe bleeding (Pulmonary hemorrhage, gastrointestinal hemorrhage, etc.)
- Intracranial hemorrhage as confirmed by CT scanning
- Hemodynamic instability despite use of vasopressor agents and cardiac stimulants
- Heparin hypersensitivity
- Serious systemic infectious diseases (sepsis, etc.)
- Platelet count less than 30,000/mm3
- Serious hepatic dysfunction
- Serious renal impairment
- Using percutaneous cardiopulmonary support (PCPS)
- Using continuous hemodiafiltration (CHDF)
- 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)
- The patient's core body temperature cannot be monitored
- Currently participating in another clinical trial or has participated in another clinical trial within the past six months
- in the judgement of an investigator or sub-investigator, participation in this clinical trial is inappropriate for the patient
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2016
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01847482
Start Date
March 1 2013
End Date
January 19 2016
Last Update
June 27 2018
Active Locations (10)
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1
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan, 802-8555
2
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan, 060-8543
3
Hyogo College of Medicine Hospital
Nishinomiya, Hyōgo, Japan, 663-8501
4
Iwate Medical University Hospital
Morioka, Iwate, Japan, 020-8505