Discrete Hypothermia in the Management of Traumatic Brain Injury

NCT00676104 | Completed Phase 3 DMC

• 1 other identifier: 0584-2005
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Traumatic Brain Injury; Trauma; Hypothermia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• Functional Independence Measure

  Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury

• Mortality

  Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury

• Confirm the effectiveness of the Discrete Cerebral System in reducing internal brain temperature

  within 3 days after injury

Study Arms (2)

Treatment

EXPERIMENTAL

Device: CoolSystems Discrete Cerebral Hypothermia System

Control

SHAM COMPARATOR

Device: CoolSystems Discrete Cerebral Hypothermia System

Interventions

CoolSystems Discrete Cerebral Hypothermia System DEVICE

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

Control; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University School of Medicine, Grady Health System campus

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Wounds and Injuries; Hypothermia

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Odette A Harris, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Designated Investigator

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 12, 2008
• Study Start: July 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: October 1, 2008
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

US (1)