Traumatic Brain InjuryNCT01940861
Cerebral Oxymetry in Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Vasopressor for current treatment protocols for acute traumatic brain injury can lead to vasoconstriction and thus cerebral hypoperfusion that can be detected with cerebral oxymetry as a drop in SCO2. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2014to Dec 2016
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: TBI
Who may be able to join
- Patients with acute traumatic severe brain injury requiring neuro intensive care.
- The patient admitted must be at least 18 years of age and under 60 years.
- Intoxication is not an obstacle for inclusion as we believe this will not affect the recording in relation to our problem.
Who cannot join
- Traumatic injury in the frontal lobes corresponding to the area where ScO2 monitored.
- Patients in pharmacological studies.
- Patients with severe heart / lung / blood vessel diseases.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, Oslo, 0424
Ove Andreas Hagen, MD, +4790634748, ovahagen@online.no
Ove A. Hagen, MD
About this study
Vasopressor for current treatment protocols for acute traumatic brain injury can lead to vasoconstriction and thus cerebral hypoperfusion that can be detected with cerebral oxymetry as a drop in SCO2.
- Conditions
- Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Traumatic brain injury | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of vasopressor
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startNov 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940861
- Sponsor's protocol ID
- Co-TBI
- Other IDs
- 2010/824
- Status last verified
- Nov 2014
- First submitted
- 9 Sep 2013
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxymetry in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01940861
- Acronym / sponsor ID
- Co-TBI
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 Sep 2013 (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.
Vasopressor for current treatment protocols for acute traumatic brain injury can lead to vasoconstriction and thus cerebral hypoperfusion that can be detected with cerebral oxymetry as a drop in SCO2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic brain injury | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- TBI
Key inclusion criteria (3 listed)
- Patients with acute traumatic severe brain injury requiring neuro intensive care.
- The patient admitted must be at least 18 years of age and under 60 years.
- Intoxication is not an obstacle for inclusion as we believe this will not affect the recording in relation to our problem.
Key exclusion criteria (3 listed)
- Traumatic injury in the frontal lobes corresponding to the area where ScO2 monitored.
- Patients in pharmacological studies.
- Patients with severe heart / lung / blood vessel diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dosage of vasopressor
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Oslo University Hospital at 1 site in Norway.
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 3 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: status not confirmed, as of the sponsor's last update on 24 Nov 2014. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of vasopressor (time frame: 24 hours). 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 24 Nov 2014.