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Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

NCT00134472 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-05-11

No results posted yet for this study

Summary

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

Conditions

  • Brain Injuries, Traumatic

Interventions

PROCEDURE

Therapeutic mild hypothermia

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

Sponsors & Collaborators

  • University Hospital Medical Information Network

    collaborator OTHER

  • Japan Clinical Research Support Unit(J-CRSU)

    collaborator UNKNOWN

  • Yamaguchi University Hospital

    lead OTHER

Principal Investigators

  • Tsuyoshi Maekawa, MD, PhD · Yamaguchi University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00134472 on ClinicalTrials.gov