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Discrete Hypothermia in the Management of Traumatic Brain Injury

NCT ID: NCT00676104

Last Updated: 2013-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Traumatic Brain Injury

Keywords

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Traumatic Brain Injury Trauma Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type EXPERIMENTAL

CoolSystems Discrete Cerebral Hypothermia System

Intervention Type DEVICE

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

Control

Group Type SHAM_COMPARATOR

CoolSystems Discrete Cerebral Hypothermia System

Intervention Type DEVICE

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

Interventions

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CoolSystems Discrete Cerebral Hypothermia System

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient is treated for severe traumatic brain injury at Grady Health System, GCS \< 8
* Patient is \>18 years of age
* Patient requires an Intracranial Pressure (ICP) Probe (part of their routine treatment)
* Patient is able to receive Discrete Cerebral Hypothermia within 48-hours of hospital admission
* Patient and/or guardian must speak English (in order to ensure proper Informed Consent)
* Patient and/or guardian/family must sign an Informed Consent

Exclusion Criteria

* Unwillingness or inability of patient and/or guardian/ family to sign an informed consent
* Physical placement of cooling cap impedes routine treatment
* Patient has a core body temperature of 36 degrees C or less at time of assessment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Monique Surles

Designated Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Odette A Harris, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University School of Medicine, Grady Health System campus

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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0584-2005

Identifier Type: -

Identifier Source: org_study_id