Traumatic Brain InjuryPhase 2NCT00170352
Comparison Between Different Types of Oxygen Treatment Following Traumatic Brain Injury
A Phase 2 study testing Hyperbaric Oxygen Treatment (HBOT) and Enhanced Oxygen Treatment (Enhanced FiO2) in people with Traumatic Brain Injury, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to study the effects of EARLY (no more than 24 four hours from injury) administration of extra amounts of oxygen on traumatic brain injury. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Hyperbaric Oxygen Treatment (HBOT) and Enhanced Oxygen Treatment (Enhanced FiO2)
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Nov 2008
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All closed head trauma victims with GCS score < 8, when no effects from paralytics, sedation, alcohol and/or street drugs are present.
- Informed consent obtained.
- Entry into the study within 24 hours after injury.
- If a patient enters the hospital with a mild or moderate brain injury and subsequently deteriorates to a GCS < 8 within 48 hours of admission, the patient is considered a candidate for entry into the study.
- CT scan score > II in accordance with the classification system of the Traumatic Coma Data Bank.
Who cannot join
- Consent could not be obtained.
- Patients who are brain dead or close to brain death (fixed, dilated pupils).
- Unstable pulmonary status requiring FiO2 of 50% or greater to maintain a PaO2 of 70 mm Hg or greater.
- History of severe pulmonary disease, such as COPD or asthma.
- Unstable fracture (spine, pelvis, femur, etc) preventing placement into the HBO chamber.
- Patients placed in barbiturate coma during initial management due to the potential effect barbiturates have on cerebral metabolism.
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- Age range < 16 years or > 65 years.
- Coagulopathy.
- Pregnancy.
- Severe mental retardation or prior severe head injury.
- High velocity penetrating injury to the head,(e.g. gunshot wound).
- Multiple organ failure.
- Massive cerebral hemisphere or brainstem hematoma, stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: Hyperbaric and Normobaric Oxygen in Severe Brain Injury
The purpose of this study is to study the effects of EARLY (no more than 24 four hours from injury) administration of extra amounts of oxygen on traumatic brain injury.
Read the detailed description
Brain injury continues to be a major cause of death and disability throughout the world. Our investigations of hyperbaric oxygen treatment (HBOT) indicate that it is a relatively safe treatment that has promise as a potential therapy for patients with severe traumatic brain injury (TBI). The goals of the present proposal are to further elucidate the mechanisms of action of HBOT on severe TBI and to test hypotheses that are crucial to the possible future design of a Phase III clinical trial.
Our initial prospective clinical trial to assess the effectiveness of HBOT in severe TBI documented very significant improvement in survival, particularly in certain subgroups of patients. In our second study, HBOT was found to improve cerebral aerobic metabolism in patients with severe TBI, reduce elevated intracranial pressure, and had a persistent positive effect for at least six hours following the treatment. Our work suggests that HBOT allows the brain to utilize increased amounts of oxygen more efficiently following treatment.
Recently, increasing the inspired oxygen concentration (FiO2) to 100% has been proposed as an alternative way of delivering supranormal levels of oxygen to severe TBI patients. Experimental investigation in the fluid percussion rat model using HBOT at 1.5 ATA (atmospheres absolute) for 60 minutes followed by 3 hours of 100%fraction of inspired oxygen (FiO2) have given optimum results in terms of mitochondrial functional and neurobehavioral improvement.
The clinical and experimental data together provide a strong basis for the restorative effect of the combination of hyper- and normobaric hyperoxia on severe TBI. The goal of this study is to evaluate the use of HBOT and 100% FiO2 separately and in combination.
- Conditions
- Traumatic Brain Injury
- Being tested
- Hyperbaric Oxygen Treatment (HBOT), Enhanced Oxygen Treatment (Enhanced FiO2)
- Keywords
- hyperbaric oxygen, cerebral metabolism, hyperoxia, traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen Treatment (HBOT)Procedure or surgery
Enhanced Oxygen Treatment (Enhanced FiO2)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Metabolic Rate of Oxygen (CMRO2)
Microdialysis Lactate
Brain tissue oxygen (PtO2)
Intracranial Pressure (ICP)
Secondary outcomes (6)
Microdialysis-Glycerol,Glucose,Pyruvate,Lactate/Pyruvate Ratio
Cerebral Spinal Fluid (CSF) Lactate
Arterial-Venous Oxygen Difference (AVDO2)
Cerebral Blood Flow (CBF)
Cerebral Spinal Fluid Isoprostane
Bronchial-Alveolar Lavage Cytokines
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 2002
- Primary completionNov 2007
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Gaylan L Rockswold, M.D., PhD, Principal investigator, Hennepin County Medical Center, MinneapolisSarah B Rockswold, M.D., Study director, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170352
- Sponsor's protocol ID
- HSR2000-858
- Other IDs
- NIH-5 RO1 NS042126-03
- Status last verified
- Aug 2015
- First submitted
- 12 Sep 2005
- Last updated
- 28 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rockswold SB, Rockswold GL, Zaun DA, Liu J. A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury. J Neurosurg. 2013 Jun;118(6):1317-28. doi: 10.3171/2013.2.JNS121468. Epub 2013 Mar 19.
PubMed 23510092
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric and Normobaric Oxygen in Severe Brain Injury
- ClinicalTrials.gov ID
- NCT00170352
- Acronym / sponsor ID
- HSR2000-858
- Conditions
- Traumatic Brain Injury
- Keywords
- hyperbaric oxygen, cerebral metabolism, hyperoxia, traumatic brain injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 15 Sep 2005 (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 study is to study the effects of EARLY (no more than 24 four hours from injury) administration of extra amounts of oxygen on traumatic brain injury.
Detailed description
Brain injury continues to be a major cause of death and disability throughout the world. Our investigations of hyperbaric oxygen treatment (HBOT) indicate that it is a relatively safe treatment that has promise as a potential therapy for patients with severe traumatic brain injury (TBI). The goals of the present proposal are to further elucidate the mechanisms of action of HBOT on severe TBI and to test hypotheses that are crucial to the possible future design of a Phase III clinical trial.
Our initial prospective clinical trial to assess the effectiveness of HBOT in severe TBI documented very significant improvement in survival, particularly in certain subgroups of patients. In our second study, HBOT was found to improve cerebral aerobic metabolism in patients with severe TBI, reduce elevated intracranial pressure, and had a persistent positive effect for at least six hours following the treatment. Our work suggests that HBOT allows the brain to utilize increased amounts of oxygen more efficiently following treatment.
Recently, increasing the inspired oxygen concentration (FiO2) to 100% has been proposed as an alternative way of delivering supranormal levels of oxygen to severe TBI patients. Experimental investigation in the fluid percussion rat model using HBOT at 1.5 ATA (atmospheres absolute) for 60 minutes followed by 3 hours of 100%fraction of inspired oxygen (FiO2) have given optimum results in terms of mitochondrial functional and neurobehavioral improvement.
The clinical and experimental data together provide a strong basis for the restorative effect of the combination of hyper- and normobaric hyperoxia on severe TBI. The goal of this study is to evaluate the use of HBOT and 100% FiO2 separately and in combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- All closed head trauma victims with GCS score < 8, when no effects from paralytics, sedation, alcohol and/or street drugs are present.
- Informed consent obtained.
- Entry into the study within 24 hours after injury.
- If a patient enters the hospital with a mild or moderate brain injury and subsequently deteriorates to a GCS < 8 within 48 hours of admission, the patient is considered a candidate for entry into the study.
- CT scan score > II in accordance with the classification system of the Traumatic Coma Data Bank.
Key exclusion criteria (13 listed)
- Consent could not be obtained.
- Patients who are brain dead or close to brain death (fixed, dilated pupils).
- Unstable pulmonary status requiring FiO2 of 50% or greater to maintain a PaO2 of 70 mm Hg or greater.
- History of severe pulmonary disease, such as COPD or asthma.
- Unstable fracture (spine, pelvis, femur, etc) preventing placement into the HBO chamber.
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 |
|---|---|---|
| Hyperbaric Oxygen Treatment (HBOT) | Procedure or surgery | – |
| Enhanced Oxygen Treatment (Enhanced FiO2) | Procedure or surgery | – |
Primary outcome
Cerebral Metabolic Rate of Oxygen (CMRO2)
Microdialysis Lactate
Brain tissue oxygen (PtO2)
Intracranial Pressure (ICP)
6 secondary outcomes
Microdialysis-Glycerol,Glucose,Pyruvate,Lactate/Pyruvate Ratio
Cerebral Spinal Fluid (CSF) Lactate
Arterial-Venous Oxygen Difference (AVDO2)
Cerebral Blood Flow (CBF)
Cerebral Spinal Fluid Isoprostane
Bronchial-Alveolar Lavage Cytokines
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 28 Aug 2015.
- Derived from this study: PubMed 23510092Rockswold SB, Rockswold GL, Zaun DA, Liu J. A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury. J Neurosurg. 2013 Jun;118(6):1317-28. doi: 10.3171/2013.2.JNS121468. Epub 2013 Mar 19.
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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.
Gaylan L Rockswold, M.D., PhD principal investigator
Hennepin County Medical Center, Minneapolis
Sarah B Rockswold, M.D. study director
Hennepin County Medical Center, Minneapolis
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 Hyperbaric Oxygen Treatment (HBOT) and Enhanced Oxygen Treatment (Enhanced FiO2) in people with Traumatic Brain Injury, run by Hennepin Healthcare Research Institute 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 5 inclusion and 13 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 28 Aug 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?
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.
What does the primary outcome measure?
Cerebral Metabolic Rate of Oxygen (CMRO2). The study lists 4 primary outcomes in all. 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 NCT00170352, which also lists 1 linked publication.
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 Aug 2015.