MedTrace Logo

Discrete Hypothermia in the Management of Traumatic Brain Injury

NCT00676104 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2013-12-20

No results posted yet for this study

Summary

The primary goal of this project is to demonstrate the feasibility and clinical benefits of a new rapid treatment for secondary treatment for secondary brain injury called Discrete Cerebral Hypothermia System by CoolSystems, Inc., Berkley, CA. This device induced hypothermia in the adult brain without significant whole body hypothermia. Discrete Cerebral Hypothermia System holds a great potential for protecting the brain from the devastating secondary complications of trauma without the associated deleterious system effects.

Conditions

  • Severe Traumatic Brain Injury

Interventions

DEVICE

CoolSystems Discrete Cerebral Hypothermia System

The CoolSystems Discrete Cerebral Hypothermia System (DCHS) will be removed from the patients head after 48 hours.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Odette A Harris, MD, MPH · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-08-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00676104 on ClinicalTrials.gov