NCT01847482

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 6, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2016

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

February 11, 2013

Last Update Submit

June 25, 2018

Conditions

Cardiac Arrest

Keywords

Cardiac arrestReturn of Spontaneous Circulation (ROSC)IntraVascular Temperature Management (IVTM)Therapeutic HypothermiaJapan

Outcome Measures

Primary Outcomes (1)

  • Core temperature achievement ratio

    Baseline and 3 hours

Secondary Outcomes (6)

  • Cerebral Performance Category (CPC)

    Baseline and 14 days

  • Modified Rankin Scale (mRS)

    Baseline and 14 days

  • Change in body temperature

    Baseline and 96 hours

  • Cooling speed

    Baseline and 3 hours

  • Safety

    Baseline vs. 2 days

  • +1 more secondary outcomes

Study Arms (1)

Therapeutic Hypothermia

EXPERIMENTAL
Device: ZOLL Intravascular Temperature Management System (IVTM)

Interventions

ZOLL Intravascular Temperature Management System (IVTM)DEVICE

Induced therapeutic hypothermia post cardiac arrest

Therapeutic Hypothermia

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

Location

Sapporo Medical University Hospital

Sapporo, Hokkaido, 060-8543, Japan

Location

Hyogo College of Medicine Hospital

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Iwate Medical University Hospital

Morioka, Iwate, 020-8505, Japan

Location

Kagawa University School of Medicine

Hiragi, Kagawa-ken, 761-0793, Japan

Location

Nipponn Medical School Hospital

Bunkyo, Tokyo, 113-8603, Japan

Location

Surugadai Nihon University Hospital

Chiyoda City, Tokyo, 101-8309, Japan

Location

Yamaguchi University Hospital

Ube, Yamaguchi, 755-8505, Japan

Location

National Hospital Organization Kumamoto Medical Center

Kumamoto, 860-0008, Japan

Location

Osaka City General Hospital

Osaka, 534-0021, Japan

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Yoichi Kato, PhD

    Asahi Kasei Medical Co., Ltd.

    STUDY DIRECTOR

  • Tsuyoshi Maekawa, MD, PhD

    Yamaguchi Grand Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2013

First Posted

May 6, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2014

Study Completion

January 19, 2016

Last Updated

June 27, 2018

Record last verified: 2014-06

Locations

JP(10)