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

• 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

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.

• 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

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)