Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

Yamaguchi University Hospital

Status and phase

Completed

Phase 3

Conditions

Brain Injuries, Traumatic

Treatments

Procedure: Therapeutic mild hypothermia

Study type

Interventional

Funder types

Other

Identifiers

NCT00134472

H16-HEART-01

H14-HEART-005

H15-HEART-01

Details and patient eligibility

About

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

Full 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.

Enrollment

150 patients

Sex

All

Ages

15 to 69 years old

Volunteers

No Healthy Volunteers

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