Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

This study has been completed.

Sponsor:

Collaborators:

University hospital Medical Information Network(UMIN, Japan)

Japan Clinical Research Support Unit(J-CRSU)

Information provided by (Responsible Party):

Tsuyoshi Maekawa, Yamaguchi University Hospital

ClinicalTrials.gov Identifier:

NCT00134472

First received: August 23, 2005

Last updated: May 10, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 23, 2005

Last Updated Date

May 10, 2012

Start Date ^ICMJE

December 2002

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Neurological outcome [ Time Frame: six months after the onset ] [ Designated as safety issue: No ]
Glasgow outcome score and neuropsychological performance at 6 months after injury.
Total medical expenses [ Time Frame: whole duration of treatment ] [ Designated as safety issue: No ]
Total medical expenses would be compared.

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00134472 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Physiological data [ Time Frame: each day during the treatment ] [ Designated as safety issue: No ]
Laboratory data [ Time Frame: each day during the treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Physiological data
Laboratory data

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

Official Title ^ICMJE

Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Brain Injuries, Traumatic

Intervention ^ICMJE

Procedure: Therapeutic mild hypothermia

Keeping 32 - 34 degree celsius of core temperature at least for 72 hours.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

15 Years to 69 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00134472

Other Study ID Numbers ^ICMJE

H14-HEART-005, H15-HEART-01, H16-HEART-01

Has Data Monitoring Committee

Not Provided

Responsible Party

Tsuyoshi Maekawa, Yamaguchi University Hospital

Study Sponsor ^ICMJE

Yamaguchi University Hospital

Collaborators ^ICMJE

University hospital Medical Information Network(UMIN, Japan)
Japan Clinical Research Support Unit(J-CRSU)

Investigators ^ICMJE

Principal Investigator:

Tsuyoshi Maekawa, MD, PhD

Yamaguchi University Hospital

Information Provided By

Yamaguchi University Hospital

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top