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
  Purpose

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 Intervention Phase
Traumatic Brain Injury
Device: Arctic Sun
Drug: Magnesium Sulfate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Department of Defense:

Primary Outcome Measures:
  • 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)



Secondary Outcome Measures:
  • 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


Enrollment: 6
Study Start Date: December 2011
Study Completion Date: June 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional Therapy
Experimental: Hypothermia
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333488

Locations
United States, Florida
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Sponsors and Collaborators
Investigators
Principal Investigator: Greg Zorman, MD Memorial Healthcare System
  More Information

No publications provided

Responsible Party: Greg Zorman, Chief of Neurosurgery, Department of Defense
ClinicalTrials.gov Identifier: NCT01333488     History of Changes
Other Study ID Numbers: MHS TBI Study
Study First Received: April 8, 2011
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Department of Defense:
Traumatic
Brain
Injury

Additional relevant MeSH terms:
Hypothermia
Brain Injuries
Wounds and Injuries
Body Temperature Changes
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on August 28, 2014