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

Phase 2

Terminated

• Conditions: Traumatic Brain Injury
• Interventions: Device: Arctic Sun; Drug: Magnesium Sulfate

• Registration Number: NCT01333488
• Lead Sponsor: United States Department of Defense

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-08
• Study First Submitted QC: 2011-04-11
• Study First Posted: 2011-04-12
• Study Start: 2011-12
• Primary Completion: 2014-03
• Study Completion: 2014-06
• Results First Submitted: 2015-08-04
• Results First Submitted QC: 2015-08-31
• Results First Posted: 2015-09-30
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypothermia	Arctic Sun	Subjects will have their core body temperatures lowered to 34C.
Hypothermia plus supplemental magnesium sulfate infusion	Arctic Sun	-
Hypothermia plus supplemental magnesium sulfate infusion	Magnesium Sulfate	-

Primary Outcome Measures

Name	Time	Method
GOS (Glasgow Outcome Score)	Discharge from Hospital - Within 2 months from Injury	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

Name	Time	Method
GOS	12 months after injury	GOS score
Vasospasm	up to 3 months	as measured by TCD (Transcranial Doppler)

Trial Locations

Locations (1)

Memorial Regional Hospital; 🇺🇸 Hollywood, Florida, United States