Traumatic Brain InjuryPhase 3NABIS:HIIRNCT00178711
Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury
A Phase 3 study testing Hypothermia in people with Traumatic Brain Injury, run by The University of Texas Health Science Center, Houston at 5 sites in 2 countries.
Trial summary
Induction of hypothermia to < 35˚C by < 2.5 hours after severe traumatic brain injury, reaching 33˚C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months after injury compared to patients randomized to normothermia. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Hypothermia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Nov 2005to Dec 2009
- Phase
- Phase 3
- 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Non-penetrating brain injury with post-resuscitation Glasgow Coma Score (GCS) < 8 (motor 1-5)
- Estimated or known age > 16 and < 45 years old
- Time of Injury within 2.5hrs of arrival at hospital
Who cannot join
- GCS = 7 or 8 with a normal head Cat Scan (CT) scan or showing only mild Subarachnoid hemorrhage (SAH)or skull fracture or GCS > 9 post- randomization
- GCS = 3 AND bilaterally non-reactive pupils
- Abbreviated Injury Score (AIS) > 4 for any body area except head
- Positive abdominal ultrasound or CT scan
- Persistent hypotension (systolic blood pressure < 110mmHGg)
- Persistent hypoxia (O2 Saturation < 94%)
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- Positive pregnancy test
- Injured greater than 2.5 hours from hospital arrival
- Pre-existing medical conditions, if known
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Charleston Area Medical Center
Charleston, West Virginia, 25304
University of Texas Health Science Center, Memorial Hermann Hospital
Houston, Texas, 77030
University of Pittsburgh : University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of St Louis : St. Louis University Hospital
St Louis, Missouri, 63110
Canada1 site
University of Calgary Health Science Center : Foothills Medical Center
Calgary, Alberta, T2N4N1
About this study
Official title: National Acute Brain Injury Study: Hypothermia IIR
Induction of hypothermia to < 35˚C by < 2.5 hours after severe traumatic brain injury, reaching 33˚C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months after injury compared to patients randomized to normothermia.
Read the detailed description
NABIS:HIIR was a randomized clinical trial conducted in patients with severe brain injury, age 16-45. Patients were randomized to standard treatment at normothermia or to standard treatment with moderate hypothermia (32.5-34C for 48 hours). An intent to treat analysis was used with the primary outcome measure as the Glasgow Outcome Scale at six months after injury. GOS is dichotomized into good outcome (Good Recovery/Moderate Disability) and poor outcome (Severe Disability, Vegetative, Dead).
- Conditions
- Traumatic Brain Injury
- Being tested
- Hypothermia
- Keywords
- Traumatic Brain Injury, Hypothermia
- Medical subject headings
- Brain Injuries, Traumatic, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypothermiaDevice
Also called moderate hypothermia
Induction of moderate hypothermia to 33 degrees celsius, within 2.5 hours from time of injury and maintained for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| hypothermia | Active comparator | Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 2.5 hours of injury and maintained for 48 hours. Receives: Device: Hypothermia |
| control | No intervention | treated at normothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Dichotomized Glasgow Outcome Scale
The primary outcome measure was the Glasgow Outcome Scale measured in person six months after injury by examiners who were blinded to the patient's treatment group. Good recovery and moderate disability were designated as favorable outcomes; severe disability, a vegetative state, and death as poor outcomes.
Measured: 6 months with a window of plus or minus one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 2005
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Futility
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Clifton, The University of Texas Health Science Center, Houston
- Investigators
- Guy L Clifton, MD, Principal investigator, UTHSC-H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178711
- Sponsor's protocol ID
- 5U01NS043353-06
- Other IDs
- FDA-2014-109
- Acronym
- NABIS:HIIR
- Status last verified
- Sep 2014
- First submitted
- 13 Sep 2005
- Last updated
- 17 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Clifton GL, Coffey CS, Fourwinds S, Zygun D, Valadka A, Smith KR Jr, Frisby ML, Bucholz RD, Wilde EA, Levin HS, Okonkwo DO. Early induction of hypothermia for evacuated intracranial hematomas: a post hoc analysis of two clinical trials. J Neurosurg. 2012 Oct;117(4):714-20. doi: 10.3171/2012.6.JNS111690. Epub 2012 Jul 27.
PubMed 22839656Clifton GL, Valadka A, Zygun D, Coffey CS, Drever P, Fourwinds S, Janis LS, Wilde E, Taylor P, Harshman K, Conley A, Puccio A, Levin HS, McCauley SR, Bucholz RD, Smith KR, Schmidt JH, Scott JN, Yonas H, Okonkwo DO. Very early hypothermia induction in patients with severe brain injury (the National Acute Brain Injury Study: Hypothermia II): a randomised trial. Lancet Neurol. 2011 Feb;10(2):131-9. doi: 10.1016/S1474-4422(10)70300-8. Epub 2010 Dec 17.
PubMed 21169065
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Acute Brain Injury Study: Hypothermia IIR
- ClinicalTrials.gov ID
- NCT00178711
- Acronym / sponsor ID
- NABIS:HIIR / 5U01NS043353-06
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Hypothermia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 232 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Nov 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 11 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Induction of hypothermia to < 35˚C by < 2.5 hours after severe traumatic brain injury, reaching 33˚C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months after injury compared to patients randomized to normothermia.
Detailed description
NABIS:HIIR was a randomized clinical trial conducted in patients with severe brain injury, age 16-45. Patients were randomized to standard treatment at normothermia or to standard treatment with moderate hypothermia (32.5-34C for 48 hours). An intent to treat analysis was used with the primary outcome measure as the Glasgow Outcome Scale at six months after injury. GOS is dichotomized into good outcome (Good Recovery/Moderate Disability) and poor outcome (Severe Disability, Vegetative, Dead).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypothermia | Active comparator | Device: HypothermiaInduction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 2.5 hours of injury and maintained for 48 hours. |
| control | No intervention | –treated at normothermia |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Non-penetrating brain injury with post-resuscitation Glasgow Coma Score (GCS) < 8 (motor 1-5)
- Estimated or known age > 16 and < 45 years old
- Time of Injury within 2.5hrs of arrival at hospital
Key exclusion criteria (9 listed)
- GCS = 7 or 8 with a normal head Cat Scan (CT) scan or showing only mild Subarachnoid hemorrhage (SAH)or skull fracture or GCS > 9 post- randomization
- GCS = 3 AND bilaterally non-reactive pupils
- Abbreviated Injury Score (AIS) > 4 for any body area except head
- Positive abdominal ultrasound or CT scan
- Persistent hypotension (systolic blood pressure < 110mmHGg)
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 |
|---|---|---|
| HypothermiaAlso: moderate hypothermiaInduction of moderate hypothermia to 33 degrees celsius, within 2.5 hours from time of injury and maintained for 48 hours | Device | hypothermia |
Primary outcome
The Dichotomized Glasgow Outcome Scale
Time frame: 6 months with a window of plus or minus one month
The primary outcome measure was the Glasgow Outcome Scale measured in person six months after injury by examiners who were blinded to the patient's treatment group. Good recovery and moderate disability were designated as favorable outcomes; severe disability, a vegetative state, and death as poor outcomes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22839656Clifton GL, Coffey CS, Fourwinds S, Zygun D, Valadka A, Smith KR Jr, Frisby ML, Bucholz RD, Wilde EA, Levin HS, Okonkwo DO. Early induction of hypothermia for evacuated intracranial hematomas: a post hoc analysis of two clinical trials. J Neurosurg. 2012 Oct;117(4):714-20. doi: 10.3171/2012.6.JNS111690. Epub 2012 Jul 27.
- Results publication: PubMed 21169065Clifton GL, Valadka A, Zygun D, Coffey CS, Drever P, Fourwinds S, Janis LS, Wilde E, Taylor P, Harshman K, Conley A, Puccio A, Levin HS, McCauley SR, Bucholz RD, Smith KR, Schmidt JH, Scott JN, Yonas H, Okonkwo DO. Very early hypothermia induction in patients with severe brain injury (the National Acute Brain Injury Study: Hypothermia II): a randomised trial. Lancet Neurol. 2011 Feb;10(2):131-9. doi: 10.1016/S1474-4422(10)70300-8. Epub 2010 Dec 17.
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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.
Guy L Clifton, MD principal investigator
UTHSC-H
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypothermia in people with Traumatic Brain Injury, run by The University of Texas Health Science Center, Houston at 5 sites in 2 countries.
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 3 inclusion and 9 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 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 11 Aug 2014). 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?
The Dichotomized Glasgow Outcome Scale (time frame: 6 months with a window of plus or minus one month). 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 NCT00178711, which also lists 2 linked publications.
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 17 Sep 2014.