Trial Outcomes & Findings for Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects (NCT NCT01333488)
NCT ID: NCT01333488
Last Updated: 2015-10-28
Results Overview
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)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Discharge from Hospital - Within 2 months from Injury
Results posted on
2015-10-28
Participant Flow
Recruitment dates from 11/3/2011 to 3/10/2014 in Level one trauma center setting. Study was closed because of low accrual.
Participant milestones
| Measure |
Conventional Therapy
Standard of Care treatment for severe traumatic brain injury.
|
Hypothermia
Subjects will have their core body temperatures lowered to 34C.
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
|
Hypothermia Plus Supplemental Magnesium Sulfate Infusion
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
3
|
|
Overall Study
COMPLETED
|
2
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects
Baseline characteristics by cohort
| Measure |
Conventional Therapy
n=2 Participants
Standard of care therapy for severe traumatic brain injury.
|
Hypothermia
n=1 Participants
Subjects will have their core body temperatures lowered to 34C.
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
|
Hypothermia Plus Supplemental Magnesium Sulfate Infusion
n=3 Participants
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
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.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
35.5 years
n=5 Participants
|
43 years
n=7 Participants
|
25.6 years
n=5 Participants
|
32 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Discharge from Hospital - Within 2 months from InjuryGOS=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)
Outcome measures
| Measure |
Conventional Therapy
n=2 Participants
Standard of Care treatment for severe traumatic brain injury.
|
Hypothermia
n=1 Participants
Subjects will have their core body temperatures lowered to 34C.
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
|
Hypothermia Plus Supplemental Magnesium Sulfate Infusion
n=3 Participants
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
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.
|
|---|---|---|---|
|
GOS (Glasgow Outcome Score)
|
3 units on a scale
Interval 1.0 to 5.0
|
3 units on a scale
Interval 3.0 to 3.0
|
3 units on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 12 months after injuryGOS score
Outcome measures
| Measure |
Conventional Therapy
n=2 Participants
Standard of Care treatment for severe traumatic brain injury.
|
Hypothermia
n=1 Participants
Subjects will have their core body temperatures lowered to 34C.
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
|
Hypothermia Plus Supplemental Magnesium Sulfate Infusion
n=3 Participants
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
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.
|
|---|---|---|---|
|
GOS
|
5 GOS score
Interval 5.0 to 5.0
|
5 GOS score
Interval 5.0 to 5.0
|
4 GOS score
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: up to 3 monthsas measured by TCD (Transcranial Doppler)
Outcome measures
| Measure |
Conventional Therapy
n=2 Participants
Standard of Care treatment for severe traumatic brain injury.
|
Hypothermia
n=1 Participants
Subjects will have their core body temperatures lowered to 34C.
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
|
Hypothermia Plus Supplemental Magnesium Sulfate Infusion
n=3 Participants
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
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.
|
|---|---|---|---|
|
Vasospasm
|
100 Percentage of participants
|
0 Percentage of participants
|
66.6 Percentage of participants
|
Adverse Events
Conventional Therapy
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Hypothermia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hypothermia Plus Supplemental Magnesium Sulfate Infusion
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conventional Therapy
n=2 participants at risk
Standard of care therapy for severe traumatic brain injury.
|
Hypothermia
n=1 participants at risk
Subjects will have their core body temperatures lowered to 34C.
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
|
Hypothermia Plus Supplemental Magnesium Sulfate Infusion
n=3 participants at risk
Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
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.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
0.00%
0/2 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
0.00%
0/1 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
33.3%
1/3 • Number of events 1 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
|
Cardiac disorders
sustained sinus tachycardia
|
50.0%
1/2 • Number of events 1 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
0.00%
0/1 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
0.00%
0/3 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
|
Cardiac disorders
Cardiopulmonary Arrest
|
0.00%
0/2 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
0.00%
0/1 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
33.3%
1/3 • Number of events 1 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
50.0%
1/2 • Number of events 1 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
0.00%
0/1 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
0.00%
0/3 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/2 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
0.00%
0/1 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
66.7%
2/3 • Number of events 2 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
0.00%
0/1 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
33.3%
1/3 • Number of events 1 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
|
Renal and urinary disorders
Left urethral Stone
|
0.00%
0/2 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
0.00%
0/1 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
33.3%
1/3 • Number of events 1 • SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.
8 SAEs in total No non-serious AEs were collected.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI must obtain permission from sponsor to publish any data related to this trial.
- Publication restrictions are in place
Restriction type: OTHER