Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects
The investigators hypothesize that hypothermia (body cooling) and additional magnesium sulfate will improve the outcome of severe Traumatic Brain Injury (TBI) patients.
This is a study to compare the outcomes of patients with severe traumatic brain injury who have been allocated to one of the following three groups:
Group 1 - Conventional therapy following traumatic brain injury Group 2 - Subjects will have their core body temperature lowered to 34C Group 3 - Subjects will have their core body temperature lowered to 34C and will receive a supplemental intravenous infusion of magnesium sulfate.
|Traumatic Brain Injury||Device: Arctic Sun Drug: Magnesium Sulfate||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 2, Randomized, Controlled 2x3 Trial Comparing Clinical Outcomes in Patients With Severe Traumatic Brain Injury Using Mild Hypothermia and Concurrent and Supplemental Infusion of Magnesium Sulfate.|
- GOS (Glasgow Outcome Score) [ Time Frame: Discharge from Hospital - Within 2 months from Injury ]
GOS=5 (Good Recovery) - Capacity to resume normal occupational and social activities, although some there may be some minor physical or mental deficits or symptoms.
GOS=4 (Moderate Disability) - Independent and can resume almost all activities of daily living.
GOS=3 (Severe Disability) - No longer capable of engaging in most previous personal, social or work activities. Typically are partially or totally dependent on assistance from others in daily living.
GOS=2 ( Persistent Vegetative State ) GOS=1 (Dead)
- GOS [ Time Frame: 12 months after injury ]GOS score
- Vasospasm [ Time Frame: up to 3 months ]as measured by TCD (Transcranial Doppler)
|Study Start Date:||December 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|No Intervention: Conventional Therapy|
Subjects will have their core body temperatures lowered to 34C.
Device: Arctic Sun
Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
|Experimental: Hypothermia plus supplemental magnesium sulfate infusion||
Device: Arctic Sun
Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.Drug: Magnesium Sulfate
IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333488
|United States, Florida|
|Memorial Regional Hospital|
|Hollywood, Florida, United States, 33021|
|Principal Investigator:||Greg Zorman, MD||Memorial Healthcare System|