Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects
|ClinicalTrials.gov Identifier: NCT01333488|
Recruitment Status : Terminated (Low accrual)
First Posted : April 12, 2011
Results First Posted : September 30, 2015
Last Update Posted : October 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Device: Arctic Sun Drug: Magnesium Sulfate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||June 2014|
|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.
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333488
|United States, Florida|
|Memorial Regional Hospital|
|Hollywood, Florida, United States, 33021|
|Principal Investigator:||Greg Zorman, MD||Memorial Healthcare System|