Traumatic Brain Injury | PatientBRAINOXYNCT01201291
Impact of Inspired Oxygen Fraction on Outcome in Patients With Traumatic Brain Injury
A study testing Normobaric oxygen in people with Traumatic Brain Injury | Patient, run by Kuopio University Hospital at 4 sites in Finland.
Trial summary
Aim of the study is to investigate the impact of two different fractions of inspired oxygen (FiO2) on outcome in patients with severe traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury | Patient
- What is being tested?
- Normobaric oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 4 sitesFinland
- Study dates
- Nov 2010to 1 Aug 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with isolated non-penetrating traumatic brain injury
- Multiple trauma patient with brain injury and traumas outside abdomen, thorax or pelvis not affecting oxygenation
- Glasgow coma scale eight or less (inclusive)
- Expected need for intubation and for mechanical ventilation more than 24 hours.
- Are recruited <18 hours after admittance to ICU and
- Time from TBI is less than 36 hours
- Informed consent from patients representative
Who cannot join
- Age <18 or >65 years,
- Anticipated brain death in 12 hours (donor treatment) or otherwise moribund patient expected to die in 24 hours
- Expected need for mechanical ventilation less than 24 hours
- Insufficient oxygenation assessed by a clinician or multiple trauma patients with brain injury and severe abdominal, thoracic or pelvic injury possibly affecting oxygenation.
- No consent
- Insufficient oxygenation with the treatment modality of the lower oxygenation group (Pa02 less than 13 kPa or SpO2 95% with Fi02 40%, PEEP 10 or less) or oxygenation failure probable during ICU care (severe aspiration, multiple trauma patients with brain injury and severe abdominal, thoracic or pelvic injury possibly affecting oxygenation)
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- Penetrating TBI
- No consent
- Suspected pregnancy (perform urinary or serological pregnancy test if suspected)
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
Helsinki University Central Hospital, Töölö Hospital
Helsinki, Töölö, 00029
Kuopio University Hospital
Kuopio, 70211
Tampere University Hospital
Tampere, 33521
Turku University Hospital
Turku, 20521
About this study
Aim of the study is to investigate the impact of two different fractions of inspired oxygen (FiO2) on outcome in patients with severe traumatic brain injury (TBI).
Read the detailed description
The high oxygen group is treated during mechanical ventilation with either a fraction of inspired oxygen of 0.7 (high oxygen group) or a fraction of inspired oxygen 0.4 (control group). The intervention continues until withdrawal of mechanical ventilation, ICU discharge or until 14 days from ICU randomisation.
Primary outcome is worse than expected outcome in the corresponding treatment arms based on outcome meas-ured by the probability of bad outcome using the CRASH® risk calculator (prognostic model for predicting outcome after traumatic brain injury).
Secondary outcome is occurence of lung injury during mechanical ventilation.
- Conditions
- Traumatic Brain Injury | Patient
- Being tested
- Normobaric oxygen
- Keywords
- TBI, Normobaric hyperoxia, Outcome, GOS, GOSE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normobaric oxygenOther
Fraction of inspired oxygen
| Study group | Role | What they receive |
|---|---|---|
| Fraction of inspired oxygen of 0.4 | Active comparator | Fraction of inspired normobaric oxygen of 0.4 (low oxygen group) Receives: Other: Normobaric oxygen |
| Fraction of inspired oxygen of 0.7 | Active comparator | Fraction of inspired normobaric oxygen of 0.7 (high oxygen group) Receives: Other: Normobaric oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow outcome scale(GOS) and/or Extended glasgow outcome scale (GOSE)
The study is powered to have 80% power at 5% significance level to detect a treatment effect that decreases the proportion of poor outcome from 55% to 45%.
Each patient is given an individualized tailored prognosis based on patient's baseline prognosis in a large reference population. Outcome is measured by using functional outcome score, Glasgow outcome score (GOS) and/or GOS extended (GOSE).
Measured: 6 months
Secondary outcomes (1)
6 month outcome
Combined proportion of unfavourable neurological outcomes at 6 months:
severe disability (GOSE 2-4) or death (GOSE 1):
Occurence of lung injury during mechanical ventilation: ALI-criteria or ARDS criteria used (paO2/FiO2 ratio less than 300 or 200 respectively):
Mortality at 6 months:
Proportion of surviving patients with unfavourable neurological outcome at 6 months (GOSE 2-4).
Quality of life assessment (EQ-5D) at 6 months:
Prolonged mechanical ventilation Re-intubation rates
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startNov 2010
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Why it stopped: Due to slow recruitment the study was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury | PatientStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital, Turku University Hospital, Helsinki University Central Hospital
- Responsible party
- Principal investigator, Stepani Bendel, Kuopio University Hospital
- Investigators
- Esko Ruokonen, Professor, Principal investigator, Kuopio University HospitalStepani J Bendel, MD,PhD, Study director, Kuopio University HospitalMaarit Lång, MD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201291
- Sponsor's protocol ID
- KUH5070218
- Acronym
- BRAINOXY
- Status last verified
- Aug 2018
- First submitted
- 13 Sep 2010
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inspired Oxygen Fraction on Outcome in Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01201291
- Acronym / sponsor ID
- BRAINOXY / KUH5070218
- Conditions
- Traumatic Brain Injury | Patient
- Keywords
- TBI, Normobaric hyperoxia, Outcome, GOS, GOSE
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow recruitment the study was terminated
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Tampere University Hospital, Turku University Hospital, Helsinki University Central Hospital
- Study start
- Nov 2010
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 14 Sep 2010 (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.
Aim of the study is to investigate the impact of two different fractions of inspired oxygen (FiO2) on outcome in patients with severe traumatic brain injury (TBI).
Detailed description
The high oxygen group is treated during mechanical ventilation with either a fraction of inspired oxygen of 0.7 (high oxygen group) or a fraction of inspired oxygen 0.4 (control group). The intervention continues until withdrawal of mechanical ventilation, ICU discharge or until 14 days from ICU randomisation.
Primary outcome is worse than expected outcome in the corresponding treatment arms based on outcome meas-ured by the probability of bad outcome using the CRASH® risk calculator (prognostic model for predicting outcome after traumatic brain injury).
Secondary outcome is occurence of lung injury during mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fraction of inspired oxygen of 0.4 | Active comparator | Other: Normobaric oxygenFraction of inspired normobaric oxygen of 0.4 (low oxygen group) |
| Fraction of inspired oxygen of 0.7 | Active comparator | Other: Normobaric oxygenFraction of inspired normobaric oxygen of 0.7 (high oxygen group) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with isolated non-penetrating traumatic brain injury
- Multiple trauma patient with brain injury and traumas outside abdomen, thorax or pelvis not affecting oxygenation
- Glasgow coma scale eight or less (inclusive)
- Expected need for intubation and for mechanical ventilation more than 24 hours.
- Are recruited <18 hours after admittance to ICU and
Key exclusion criteria (9 listed)
- Age <18 or >65 years,
- Anticipated brain death in 12 hours (donor treatment) or otherwise moribund patient expected to die in 24 hours
- Expected need for mechanical ventilation less than 24 hours
- Insufficient oxygenation assessed by a clinician or multiple trauma patients with brain injury and severe abdominal, thoracic or pelvic injury possibly affecting oxygenation.
- No consent
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 |
|---|---|---|
| Normobaric oxygenFraction of inspired oxygen | Other | Fraction of inspired oxygen of 0.4, Fraction of inspired oxygen of 0.7 |
Primary outcome
Glasgow outcome scale(GOS) and/or Extended glasgow outcome scale (GOSE)
Time frame: 6 months
The study is powered to have 80% power at 5% significance level to detect a treatment effect that decreases the proportion of poor outcome from 55% to 45%. Each patient is given an individualized tailored prognosis based on patient's baseline prognosis in a large reference population. Outcome is measured by using functional outcome score, Glasgow outcome score (GOS) and/or GOS extended (GOSE).
1 secondary outcome
6 month outcome
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Due to slow recruitment the study was terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Esko Ruokonen, Professor principal investigator
Kuopio University Hospital
Stepani J Bendel, MD,PhD study director
Kuopio University Hospital
Maarit Lång, MD principal investigator
Kuopio University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normobaric oxygen in people with Traumatic Brain Injury | Patient, run by Kuopio University Hospital at 4 sites in Finland.
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 7 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 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. 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 was stopped early (reason given: Due to slow recruitment the study was terminated). Results are not available in the source record.
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?
Glasgow outcome scale(GOS) and/or Extended glasgow outcome scale (GOSE) (time frame: 6 months). It is what the study was designed to measure, not a finding.
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 14 Aug 2018.