Traumatic Brain InjuryPhase 2NCT01333488

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

A Phase 2 study testing Arctic Sun and Magnesium Sulfate in people with Traumatic Brain Injury, run by United States Department of Defense at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Traumatic Brain Injury
What is being tested?: Arctic Sun and Magnesium Sulfate
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Dec 2011to Jun 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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%)

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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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Memorial Regional Hospital
Hollywood, Florida, 33021

Other trials in United States

About this study

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.

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
Being tested: Arctic Sun, Magnesium Sulfate
Keywords: Traumatic, Brain, Injury
Medical subject headings: Brain Injuries, Traumatic, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01333488
Study group	Role	What they receive
Conventional Therapy	No intervention	Not described
Hypothermia	Experimental	Subjects will have their core body temperatures lowered to 34C. Receives: Device: Arctic Sun
Hypothermia plus supplemental magnesium sulfate infusion	Experimental	Not described Receives: Device: Arctic Sun; Drug: Magnesium Sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Discharge from Hospital - Within 2 months from Injury

Secondary outcomes (2)

GOS
GOS score
Measured: 12 months after injury
Vasospasm
as measured by TCD (Transcranial Doppler)
Measured: up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Jun 2014

First posted12 Apr 2011 (estimated)
Study startDec 2011
Primary completionMar 2014
Study completionJun 2014

Why it stopped: Low accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01333488
Sponsor's protocol ID: MHS TBI Study
Status last verified: Oct 2015
First submitted: 8 Apr 2011
Last updated: 28 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma

All Traumatic Brain Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01333488
Acronym / sponsor ID: MHS TBI Study
Conditions: Traumatic Brain Injury
Keywords: Traumatic, Brain, Injury
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low accrual
Enrolment: 6 participants (actual)
Lead sponsor: United States Department of DefenseUS federal agency
Study start: Dec 2011
Primary completion: Mar 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 12 Apr 2011 (estimated)
Results: Posted 30 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Conventional Therapy	No intervention	–
Hypothermia	Experimental	Device: Arctic SunSubjects will have their core body temperatures lowered to 34C.
Hypothermia plus supplemental magnesium sulfate infusion	Experimental	Device: Arctic Sun, Drug: Magnesium Sulfate

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (12 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Arctic SunCore Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.	Device	Hypothermia, Hypothermia plus supplemental magnesium sulfate infusion
Magnesium SulfateIVI 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.	Drug	Hypothermia plus supplemental magnesium sulfate infusion

Primary outcome

GOS (Glasgow Outcome Score)
Time frame: 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)

2 secondary outcomes

GOS
Time frame: 12 months after injury
Vasospasm
Time frame: up to 3 months

Results and safety

Results posted to the registry on 30 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Conventional Therapy	2	2
Hypothermia	1	1
Hypothermia Plus Supplemental Magnesium Sulfate Infusion	3	3

Primary outcome: GOS (Glasgow Outcome Score)

Time frame: Discharge from Hospital - Within 2 months from Injury. Mean (Full Range). Unit: units on a scale

Measure	Conventional Therapy n = 2	Hypothermia n = 1	Hypothermia Plus Supplemental Magnesium Sulfate Infusion n = 3
Value	3 (1 to 5)	3 (3 to 3)	3 (1 to 5)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs were collected from the time of patient enrollment onto the study to end of participation. Patients were followed for 12 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Conventional Therapy	1 of 2 (50%)	0 of 0	Not reported
Hypothermia	0 of 1 (0%)	0 of 0	Not reported
Hypothermia Plus Supplemental Magnesium Sulfate Infusion	2 of 3 (66.7%)	0 of 0	Not reported

Limitations and caveats (from the sponsor): Low accrual leading to early termination and insufficient numbers for analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Traumatic Brain Injury

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Greg Zorman, MD principal investigator

Memorial Healthcare System

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Arctic Sun and Magnesium Sulfate in people with Traumatic Brain Injury, run by United States Department of Defense at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

GOS (Glasgow Outcome Score) (time frame: Discharge from Hospital - Within 2 months from Injury). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01333488.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.