Back to resultsMild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects
Primary Purpose
Traumatic Brain Injury
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Arctic Sun
Magnesium Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic, Brain, Injury
Eligibility Criteria
Inclusion Criteria:
- Adult males or females ≥ 18 years of age
- Subjects with Traumatic Brain Injury and a post-resuscitation Glasgow Coma Score (GCS) ≤ 8
- In-hospital and screened within 7 hours of injury.
- Able to obtain legally effective written consent from authorized representative
- Patients who are intubated and on mechanical ventilation
- Admitted to ICU
Exclusion Criteria:
- Bladder or rectal core temperature below 32C (89.6F) upon admission
- Clinical brain death
- Patients with open abdomens.
- Multiple orthopedic injuries (> 2 long bone fractures)
- Persistent hypotension (systolic blood pressure < 90mmHg)
- Persistent hypoxia (O2 Saturation < 94%)
- Persistent metabolic acidosis (Lactic acid > 5 mmol/L, arterial pH < 7.25)
- Positive serum pregnancy test
- Cardiac arrhythmia with deleterious hemodynamic effects; heart block or myocardial damage (as shown on ECG)
- History of abnormal renal function
- Significant Co-morbidity (i.e. CAD;COPD; severe coagulopathy)
- Pediatric patients (< 18 years old)
Sites / Locations
- Memorial Regional Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Conventional Therapy
Hypothermia
Hypothermia plus supplemental magnesium sulfate infusion
Arm Description
Subjects will have their core body temperatures lowered to 34C.
Outcomes
Primary Outcome Measures
GOS (Glasgow Outcome Score)
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)
Secondary Outcome Measures
GOS
GOS score
Vasospasm
as measured by TCD (Transcranial Doppler)
Full Information
NCT ID
NCT01333488
First Posted
April 8, 2011
Last Updated
October 27, 2015
Sponsor
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT01333488
Brief Title
Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects
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 Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Department of Defense
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic, Brain, Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Therapy
Arm Type
No Intervention
Arm Title
Hypothermia
Arm Type
Experimental
Arm Description
Subjects will have their core body temperatures lowered to 34C.
Arm Title
Hypothermia plus supplemental magnesium sulfate infusion
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Arctic Sun
Intervention Description
Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
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.
Primary Outcome Measure Information:
Title
GOS (Glasgow Outcome Score)
Description
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)
Time Frame
Discharge from Hospital - Within 2 months from Injury
Secondary Outcome Measure Information:
Title
GOS
Description
GOS score
Time Frame
12 months after injury
Title
Vasospasm
Description
as measured by TCD (Transcranial Doppler)
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult males or females ≥ 18 years of age
Subjects with Traumatic Brain Injury and a post-resuscitation Glasgow Coma Score (GCS) ≤ 8
In-hospital and screened within 7 hours of injury.
Able to obtain legally effective written consent from authorized representative
Patients who are intubated and on mechanical ventilation
Admitted to ICU
Exclusion Criteria:
Bladder or rectal core temperature below 32C (89.6F) upon admission
Clinical brain death
Patients with open abdomens.
Multiple orthopedic injuries (> 2 long bone fractures)
Persistent hypotension (systolic blood pressure < 90mmHg)
Persistent hypoxia (O2 Saturation < 94%)
Persistent metabolic acidosis (Lactic acid > 5 mmol/L, arterial pH < 7.25)
Positive serum pregnancy test
Cardiac arrhythmia with deleterious hemodynamic effects; heart block or myocardial damage (as shown on ECG)
History of abnormal renal function
Significant Co-morbidity (i.e. CAD;COPD; severe coagulopathy)
Pediatric patients (< 18 years old)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Zorman, MD
Organizational Affiliation
Memorial Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
12. IPD Sharing Statement
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Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects
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