Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects
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|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|
|Primary Completion Date :||March 2014|
|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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|