Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

Phase 3

Completed

• Conditions: Brain Injuries, Traumatic

• Registration Number: NCT00134472
• Lead Sponsor: Yamaguchi University Hospital

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 Timeline

• Study Start: 2002-12
• Study First Submitted: 2005-08-23
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-24
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neurological outcome	six months after the onset	Glasgow outcome score and neuropsychological performance at 6 months after injury.
Total medical expenses	whole duration of treatment	Total medical expenses would be compared.

Secondary Outcome Measures

Name	Time	Method
Laboratory data	each day during the treatment
Physiological data	each day during the treatment

Trial Locations

Locations (43)

National Hospital Organization Nagoya Medical Center; 🇯🇵 Nagoya, Aichi, Japan

Nagoya University Hospital; 🇯🇵 Nagoya, Aichi, Japan

Fujita Health University Hospital; 🇯🇵 Toyoake, Aichi, Japan

Ehime University Hospital; 🇯🇵 Toon, Ehime, Japan

Ohta Nishinouchi Hospital; 🇯🇵 Kooriyama, Fukushima, Japan

Sapporo Medical University; 🇯🇵 Sapporo, Hokkaido, Japan

The Hospital of Hyogo College of Medicine; 🇯🇵 Nishinomiya, Hyogo, Japan

Kanazawa University; 🇯🇵 Kanazawa, Ishikawa, Japan

Iwate Medical University; 🇯🇵 Morioka, Iwate, Japan

Kagawa University Hospital; 🇯🇵 Kida, Kagawa, Japan

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