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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00676104
Other study ID # 0584-2005
Secondary ID
Status Completed
Phase Phase 3
First received May 8, 2008
Last updated December 19, 2013
Start date July 2006
Est. completion date October 2008

Study information

Verified date December 2013
Source Emory University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date October 2008
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Emory University School of Medicine, Grady Health System campus Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perform a comparative analysis of outcome (Glasgow Outcome Score) Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury No
Secondary The effectiveness of the Discrete Cerebral Hypothermia System by CoolSystems in maintaining a significant gradient between the core and brain temperatures in study population. within 3 days after injury No
Secondary Functional Independence Measure Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury No
Secondary Mortality Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury No
Secondary Confirm the effectiveness of the Discrete Cerebral System in reducing internal brain temperature within 3 days after injury No
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