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: June 2, 2014
Last verified: June 2014

April 8, 2011
June 2, 2014
December 2011
March 2014   (final data collection date for primary outcome measure)
GOS (Glasgow Outcome Score) [ Time Frame: Discharge from Hospital - Within 2 months from Injury ] [ Designated as safety issue: No ]

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)

Same as current
Complete list of historical versions of study NCT01333488 on ClinicalTrials.gov Archive Site
  • GOS [ Time Frame: 3, 6 and 12 months after injury ] [ Designated as safety issue: No ]
  • Vasospasm [ Time Frame: ongoing ] [ Designated as safety issue: No ]
    as measured by TCD (Transcranial Doppler)and transcranial arteriography
Same as current
Not Provided
Not Provided
 
Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Traumatic Brain Injury
  • 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.
  • No Intervention: Conventional Therapy
  • Experimental: Hypothermia
    Subjects will have their core body temperatures lowered to 34C.
    Intervention: Device: Arctic Sun
  • Experimental: Hypothermia plus supplemental magnesium sulfate infusion
    Interventions:
    • Device: Arctic Sun
    • Drug: Magnesium Sulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
June 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Adult males or females ≥ 18 years of age
  2. Subjects with Traumatic Brain Injury and a post-resuscitation Glasgow Coma Score (GCS) ≤ 8
  3. In-hospital and screened within 7 hours of injury.
  4. Able to obtain legally effective written consent from authorized representative
  5. Patients who are intubated and on mechanical ventilation
  6. Admitted to ICU

Exclusion Criteria:

  1. Bladder or rectal core temperature below 32C (89.6F) upon admission
  2. Clinical brain death
  3. Patients with open abdomens.
  4. Multiple orthopedic injuries (> 2 long bone fractures)
  5. Persistent hypotension (systolic blood pressure < 90mmHg)
  6. Persistent hypoxia (O2 Saturation < 94%)
  7. Persistent metabolic acidosis (Lactic acid > 5 mmol/L, arterial pH < 7.25)
  8. Positive serum pregnancy test
  9. Cardiac arrhythmia with deleterious hemodynamic effects; heart block or myocardial damage (as shown on ECG)
  10. History of abnormal renal function
  11. Significant Co-morbidity (i.e. CAD;COPD; severe coagulopathy)
  12. Pediatric patients (< 18 years old)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01333488
MHS TBI Study
Yes
Greg Zorman, Department of Defense
Department of Defense
Not Provided
Principal Investigator: Greg Zorman, MD Memorial Healthcare System
Department of Defense
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP