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

NCT01333488 | Terminated Phase 2 Results DMC

• 1 other identifier: MHS TBI Study
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic; Brain; Injury

Outcome Measures

Primary Outcomes (1)

• 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)

  Discharge from Hospital - Within 2 months from Injury

Secondary Outcomes (2)

• GOS

  12 months after injury

• Vasospasm

  up to 3 months

Study Arms (3)

Conventional Therapy

NO INTERVENTION

Hypothermia

EXPERIMENTAL

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

Device: Arctic Sun

Hypothermia plus supplemental magnesium sulfate infusion

EXPERIMENTAL

Device: Arctic Sun; Drug: Magnesium Sulfate

Interventions

Arctic Sun DEVICE

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

Hypothermia; Hypothermia plus supplemental magnesium sulfate infusion

Magnesium Sulfate DRUG

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.

Hypothermia plus supplemental magnesium sulfate infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• United States Department of Defense: lead

Study Sites (1)

Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Wounds and Injuries

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Limitations and Caveats

Low accrual leading to early termination and insufficient numbers for analysis.

Results Point of Contact

• Title: Dr Greg Zorman
• Organization: Memorial Healthcare System

csareli@mhs.net

954 265 1840

Study Officials

• Greg Zorman, MD

  Memorial Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Neurosurgery

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 12, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 28, 2015
• Results First Posted: September 30, 2015

Record last verified: 2015-10

Locations

US (1)