Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

This study is currently recruiting participants.

Verified by Yamaguchi University Hospital, August 2005

First Received: August 23, 2005 Last Updated: October 28, 2005 History of Changes

Sponsors and Collaborators:	Yamaguchi University Hospital University hospital Medical Information Network(UMIN, Japan) Japan Clinical Research Support Unit(J-CRSU)
Information provided by:	Yamaguchi University Hospital
ClinicalTrials.gov Identifier:	NCT00134472

Purpose

The purpose of this trial is to determine if mild hypothermia therapy, for severe head trauma patients, improves neurological outcome.

Condition	Intervention	Phase
Brain Injuries, Traumatic	Procedure: Therapeutic mild hypothermia	Phase III

MedlinePlus related topics: Hypothermia Injuries Traumatic Brain Injury Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan

Further study details as provided by Yamaguchi University Hospital:

Primary Outcome Measures:

Neurological outcome (Glasgow outcome score and neuropsychological performance at 6 months after injury)
Total medical expenses

Secondary Outcome Measures:

Physiological data
Laboratory data

Estimated Enrollment:	300
Study Start Date:	December 2002
Estimated Study Completion Date:	September 2008

Detailed Description:

Mild hypothermia therapy shows protective effects for damaged brains of animals and post cardiac arrest patients. However, Clifton et al. reported that mild hypothermia has no protective effect for severe head trauma but has a risk of complications. In this study, all the participants must be treated with continuous monitoring of cardiac output and jugular venous oxygen saturation to get optimal physiological conditions. Adequate anesthesia such as neuroleptanesthesia is essential to maintain organ function and tissue microcirculation. Participants are randomly assigned to two groups of mild hypothermia (32.0 – 34.0 degree Celsius) and anti-hyperthermia (35.5 – 37.0 C). The body temperature must be kept for at least 72 hours. Hypothermia must be induced within 6 hours after traumatic brain injury. Glasgow outcome score at 6 months after injury and the total medical expenses of the two groups will be evaluated.

Eligibility

Ages Eligible for Study:	15 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Traumatic brain injury; Glasgow coma score 4-8 (motor 1-5).
Hypothermia or anti-hyperthermia must be induced within 6 hours after injury.

Exclusion Criteria:

Systolic blood pressure < 90mmHg (after resuscitation)
Thrombocytopenia (platelets [Plt] < 50,000/mm3)
Pregnancy
Preexisting medical conditions of severe hepatic dysfunction, heart failure or any other severe organ failure
Deep drunkenness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134472

Contacts

Contact: Tsuyoshi Maekawa, MD, PhD	+81-836-22-2343	tmaekawa@yamaguchi-u.ac.jp
Contact: Susumu Yamashita, MD	+81-836-22-2656	sum-ygc@umin.ac.jp

Show 43 Study Locations

Sponsors and Collaborators

Yamaguchi University Hospital

University hospital Medical Information Network(UMIN, Japan)

Japan Clinical Research Support Unit(J-CRSU)

Investigators

Principal Investigator:

Tsuyoshi Maekawa, MD, PhD

Yamaguchi University Hospital

More Information

Additional Information:

BHYPO: Brain Hypothermia therapy for acute head injury This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	H14-HEART-005, H15-HEART-01, H16-HEART-01
Study First Received:	August 23, 2005
Last Updated:	October 28, 2005
ClinicalTrials.gov Identifier:	NCT00134472 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Yamaguchi University Hospital:

Hypothermia, induced
Traumatic Brain injuries
Anesthesia
Neuro-intensive care
neurochemistry

Study placed in the following topic categories:

Craniocerebral Trauma
Signs and Symptoms
Hypothermia
Wounds and Injuries
Anesthetics

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Craniocerebral Trauma
Signs and Symptoms
Hypothermia
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin

Central Nervous System Diseases
Trauma, Nervous System
Body Temperature Changes
Brain Diseases
Brain Injuries

ClinicalTrials.gov processed this record on May 07, 2009