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

August 23, 2005
May 10, 2012
December 2002
September 2008   (final data collection date for primary outcome measure)
  • 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.
  • Neurological outcome (Glasgow outcome score and neuropsychological performance at 6 month after injury)
  • Total medical expenses
Complete list of historical versions of study NCT00134472 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Physiological data
  • Laboratory data
Not Provided
Not Provided
 
Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan
Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Brain Injuries, Traumatic
Procedure: Therapeutic mild hypothermia
Keeping 32 - 34 degree celsius of core temperature at least for 72 hours.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
15 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00134472
H14-HEART-005, H15-HEART-01, H16-HEART-01
Not Provided
Tsuyoshi Maekawa, Yamaguchi University Hospital
Yamaguchi University Hospital
  • University hospital Medical Information Network(UMIN, Japan)
  • Japan Clinical Research Support Unit(J-CRSU)
Principal Investigator: Tsuyoshi Maekawa, MD, PhD Yamaguchi University Hospital
Yamaguchi University Hospital
May 2012

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