Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects

This study has been terminated.
(Low accrual)
Sponsor:
Information provided by (Responsible Party):
Greg Zorman, Department of Defense
ClinicalTrials.gov Identifier:
NCT01333488
First received: April 8, 2011
Last updated: October 27, 2015
Last verified: October 2015
Results First Received: August 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Traumatic Brain Injury
Interventions: Device: Arctic Sun
Drug: Magnesium Sulfate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment dates from 11/3/2011 to 3/10/2014 in Level one trauma center setting. Study was closed because of low accrual.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Conventional Therapy Standard of Care treatment for severe traumatic brain injury.
Hypothermia

Subjects will have their core body temperatures lowered to 34C.

Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.

Hypothermia Plus Supplemental Magnesium Sulfate Infusion

Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.

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.


Participant Flow:   Overall Study
    Conventional Therapy     Hypothermia     Hypothermia Plus Supplemental Magnesium Sulfate Infusion  
STARTED     2     1     3  
COMPLETED     2     1     3  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Accrual too low to analyze

Reporting Groups
  Description
Conventional Therapy Standard of care therapy for severe traumatic brain injury.
Hypothermia

Subjects will have their core body temperatures lowered to 34C.

Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.

Hypothermia Plus Supplemental Magnesium Sulfate Infusion

Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.

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.

Total Total of all reporting groups

Baseline Measures
    Conventional Therapy     Hypothermia     Hypothermia Plus Supplemental Magnesium Sulfate Infusion     Total  
Number of Participants  
[units: participants]
  2     1     3     6  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     2     1     3     6  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean (Full Range)
  35.5  
  (25 to 46)  
  43  
  (43 to 43)  
  25.6  
  (20 to 34)  
  32  
  (20 to 46)  
Gender  
[units: participants]
       
Female     1     0     1     2  
Male     1     1     2     4  
Region of Enrollment  
[units: participants]
       
United States     2     1     3     6  



  Outcome Measures
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1.  Primary:   GOS (Glasgow Outcome Score)   [ Time Frame: Discharge from Hospital - Within 2 months from Injury ]

2.  Secondary:   GOS   [ Time Frame: 12 months after injury ]

3.  Secondary:   Vasospasm   [ Time Frame: up to 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Low accrual leading to early termination and insufficient numbers for analysis.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr Greg Zorman
Organization: Memorial Healthcare System
phone: 954 265 1840
e-mail: csareli@mhs.net



Responsible Party: Greg Zorman, Department of Defense
ClinicalTrials.gov Identifier: NCT01333488     History of Changes
Other Study ID Numbers: MHS TBI Study
Study First Received: April 8, 2011
Results First Received: August 4, 2015
Last Updated: October 27, 2015
Health Authority: United States: Food and Drug Administration
United States: Federal Government