Discrete Hypothermia in the Management of Traumatic Brain Injury

Severe Traumatic Brain Injury Clinical Trial

Official title:

Discrete Hypothermia in the Management of Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676104
• Other study ID #: 0584-2005
• 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

• Brain Injuries
• Hypothermia
• Severe Traumatic Brain Injury

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