Brain InjuriesNCT00040339
Hypothermia to Treat Severe Brain Injury
A study testing hypothermia (body temperature lowered to 33°C or 91.4°F) in people with Brain Injuries and Hypothermia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 5 sites in 2 countries.
Trial summary
The purpose of this trial is to determine if hypothermia (body cooling), administered very soon after a severe brain injury improves functional outcome. This pilot trial ended in July 2005. Please see clinicaltrials.gov record number NCT00178711 for the Phase III version of the trial (see link below). Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Brain Injuries, Hypothermia
- What is being tested?
- hypothermia (body temperature lowered to 33°C or 91.4°F)
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 5 sitesin 2 countries
- Study dates
- May 2002to Jul 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- GCS 3-8 on initial evaluation or deteriorates during transport
- Mechanism of injury consistent with blunt, non-penetrating trauma to head
- Systolic blood pressure > 110 mm Hg
- Diastolic blood pressure> 60 mm Hg
- Heart rate (pulse) < 120 beats per minute
- Estimated or known age 16-45
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- No suspicion of pregnancy
- Esophageal/rectal probe temperature > 35.5°C (Pre-hospital cooling only)
- Injured < 2 hours prior to arrival of pre-hospital providers
- No evidence of severe chest trauma (unilaterally absent breath sounds with tracheal deviation or distended neck veins or requiring thoracentesis).
- Non-penetrating brain injury with a post-resuscitation Glasgow Coma Score < 8 (motor 1-5).
Who cannot join
- Following commands upon EMS arrival without deterioration to coma or follows command after an initial period of coma.
- Mechanism of injury GSW or no indication of head injury
- Systolic blood pressure < 120 mm Hg
- Diastolic blood pressure < 60 mm Hg
- Heart rate (pulse) > 120 beats per minute
- Estimated or know age > 45 or < 16
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- Suspected pregnancy
- Forehead scan temp < 35.5°C (Pre-hospital cooling only)
- Injured >2 hours prior to arrival of pre-hospital providers
- Evidence of major chest trauma (unilaterally absent breath sounds with tracheal deviation or distended neck veins or requiring thoracentesis.
- ELIGIBILITY CRITERIA FOR 48 HOURS OF MODERATE HYPOTHERMIA (33°C):
- Glasgow Coma Score = 7 or 8 with a normal CT scan or a CT scan showing only mild subarachnoid hemorrhage or skull fracture.
- Glasgow Coma Score = 3 and bilaterally unreactive pupils.
- AIS >/= 4 for any body area except head.
- Persistent hypotension in the Emergency Department (systolic blood pressure < 90 mmHg for > 30 minutes after arrival).
- Persistent hypoxia (O2 saturation < 94%) for > 30 minutes post resuscitation.
- Unavailable for cooling within four hours of injury.
- Pre-existing medical conditions, if known.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of Cincinnati
Cincinnati, Ohio, 45221
University of Texas-Houston
Houston, Texas, 77030
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
St. Louis University
St Louis, Missouri, 63103
About this study
Official title: The National Acute Brain Injury Study: Hypothermia II (NABISH II)
The purpose of this trial is to determine if hypothermia (body cooling), administered very soon after a severe brain injury improves functional outcome. This pilot trial ended in July 2005. Please see clinicaltrials.gov record number NCT00178711 for the Phase III version of the trial (see link below).
Read the detailed description
After brain injury, the brain produces certain chemicals that are harmful to the injured tissues. Moderate hypothermia-also called body cooling-may slow or prevent the production of these chemicals. Hypothermia also decreases the amount of oxygen needed by the brain, which may provide some protection during this critical period. Earlier studies have shown that maintenance of moderate hypothermia may have a helpful effect in head injury patients ages 16 to 45 who arrive at the hospital with a low body temperature suggesting that very early cooling may be beneficial.
In this study scientists will initiate hypothermia or body cooling to 35˚C within two hours of severe brain injury to determine if body cooling improves functional outcome.
Patients may enter the study in one of two ways. They may be evaluated and surface cooling begun at the scene by emergency medical services (EMS) personnel affiliated with the study; or patients who arrive in the emergency department (ED) of the study hospital within 2 hours of injury-and who have not already been evaluated by EMS personnel affiliated with the study-will be evaluated and cooling begun, if applicable, by NABISH study personnel.
NABISH-trained EMS personnel who reach a patient with a suspected severe head injury within 2 hours of injury will induce hypothermia to 35˚C at the scene, in transit, or in the ED.
NABISH study personnel will induce hypothermia to 35˚C in the ED in patients with suspected severe head injury who reach the ED within 2 hours of injury if cooling has not already begun. Patients who meet entry criteria (based upon past studies) for moderate hypothermia for 48 hours will then be cooled to 33˚C and then gradually rewarmed after 48 hours at 33˚C. Patients initially cooled to 35˚C within 2 hours of injury who prove during trauma evaluation to have exclusion criteria for 48 hours of moderate hypothermia will be warmed from 35˚C to 37˚C.
This pilot trial ended in July 2005. Please see clinicaltrials.gov record number NCT00178711 for the Phase III version of the trial (see link below).
- Conditions
- Brain Injuries, Hypothermia
- Being tested
- hypothermia (body temperature lowered to 33°C or 91.4°F)
- Keywords
- brain injury, hypothermia, body cooling, body temperature
- Medical subject headings
- Brain Injuries, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypothermia (body temperature lowered to 33°C or 91.4°F)Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2002 (estimated)
- Study startMay 2002
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Enrolment
- 42 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Guy L. Clifton, M.D., Principal investigator, Professor and Chair, Department of Neurosurgery, University of Texas-Houston, Houston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040339
- Sponsor's protocol ID
- R01NS43353
- Status last verified
- Dec 2007
- First submitted
- 24 Jun 2002
- Last updated
- 8 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The National Acute Brain Injury Study: Hypothermia II (NABISH II)
- ClinicalTrials.gov ID
- NCT00040339
- Acronym / sponsor ID
- R01NS43353
- Conditions
- Brain Injuries, Hypothermia
- Keywords
- brain injury, hypothermia, body cooling, body temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- May 2002
- Study completion
- Jul 2005 (actual)
- First posted
- 25 Jun 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to determine if hypothermia (body cooling), administered very soon after a severe brain injury improves functional outcome. This pilot trial ended in July 2005. Please see clinicaltrials.gov record number NCT00178711 for the Phase III version of the trial (see link below).
Detailed description
After brain injury, the brain produces certain chemicals that are harmful to the injured tissues. Moderate hypothermia-also called body cooling-may slow or prevent the production of these chemicals. Hypothermia also decreases the amount of oxygen needed by the brain, which may provide some protection during this critical period. Earlier studies have shown that maintenance of moderate hypothermia may have a helpful effect in head injury patients ages 16 to 45 who arrive at the hospital with a low body temperature suggesting that very early cooling may be beneficial.
In this study scientists will initiate hypothermia or body cooling to 35˚C within two hours of severe brain injury to determine if body cooling improves functional outcome.
Patients may enter the study in one of two ways. They may be evaluated and surface cooling begun at the scene by emergency medical services (EMS) personnel affiliated with the study; or patients who arrive in the emergency department (ED) of the study hospital within 2 hours of injury-and who have not already been evaluated by EMS personnel affiliated with the study-will be evaluated and cooling begun, if applicable, by NABISH study personnel.
NABISH-trained EMS personnel who reach a patient with a suspected severe head injury within 2 hours of injury will induce hypothermia to 35˚C at the scene, in transit, or in the ED.
NABISH study personnel will induce hypothermia to 35˚C in the ED in patients with suspected severe head injury who reach the ED within 2 hours of injury if cooling has not already begun. Patients who meet entry criteria (based upon past studies) for moderate hypothermia for 48 hours will then be cooled to 33˚C and then gradually rewarmed after 48 hours at 33˚C. Patients initially cooled to 35˚C within 2 hours of injury who prove during trauma evaluation to have exclusion criteria for 48 hours of moderate hypothermia will be warmed from 35˚C to 37˚C.
This pilot trial ended in July 2005. Please see clinicaltrials.gov record number NCT00178711 for the Phase III version of the trial (see link below).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- GCS 3-8 on initial evaluation or deteriorates during transport
- Mechanism of injury consistent with blunt, non-penetrating trauma to head
- Systolic blood pressure > 110 mm Hg
- Diastolic blood pressure> 60 mm Hg
- Heart rate (pulse) < 120 beats per minute
Key exclusion criteria (18 listed)
- Following commands upon EMS arrival without deterioration to coma or follows command after an initial period of coma.
- Mechanism of injury GSW or no indication of head injury
- Systolic blood pressure < 120 mm Hg
- Diastolic blood pressure < 60 mm Hg
- Heart rate (pulse) > 120 beats per minute
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 |
|---|---|---|
| hypothermia (body temperature lowered to 33°C or 91.4°F) | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2008.
- Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury (NABIS:HIIR) Phase III trial informationLink provided by the sponsor.
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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, M.D. principal investigator
Professor and Chair, Department of Neurosurgery, University of Texas-Houston, Houston Medical Center
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypothermia (body temperature lowered to 33°C or 91.4°F) in people with Brain Injuries and Hypothermia, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 11 inclusion and 18 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: finished, as of the sponsor's last update on 8 Jan 2008. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 8 Jan 2008.