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Completed

NCT Number: NCT00134472

Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

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

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Key information

Conditions

Brain Injuries, Traumatic Body Temperature Changes Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Hypothermia Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

15 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nagoya University Hospital, Nagoya, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic mild hypothermia

Procedure

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

Primary outcomes

  1. Neurological outcome

    Time frame: six months after the onset

    Glasgow outcome score and neuropsychological performance at 6 months after injury.

  2. Total medical expenses

    Time frame: whole duration of treatment

    Total medical expenses would be compared.

Secondary outcomes

  1. Physiological data

    Time frame: each day during the treatment

  2. Laboratory data

    Time frame: each day during the treatment

Sponsors and collaborators

Lead sponsor

Yamaguchi University Hospital

Other

Collaborators

  • Japan Clinical Research Support Unit(J-CRSU)
  • University Hospital Medical Information Network

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Aug 24, 2005
Registry last updated
May 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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