Systemic Oxygenation vs ROS Formation in TBI PatientsROS-TBINCT05101278
ROS in TBI Patients in Relation to Level of Oxygenation.
An observational study of Systemic Oxygenation vs ROS Formation in TBI Patients, run by Region Stockholm at 1 site in Sweden.
Trial summary
This project an observational study performed on patients with severe Traumatic Brain Injury (TBI) treated at Neurosurgical ICU (NICU) at Karolinska University Hospital. The purpose of this study is to evaluate the effects of various oxygenation levels on production rate of Reactive Oxygen Species (ROS) in patients… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Systemic Oxygenation vs ROS Formation in TBI Patients
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2022to Dec 2024
- 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 100 years
- All sexes
- Adult, Older adult
Study population: Patients with severe isolated TBI with established intracranial monitoring (based on clinical desision), inclusion between 0 to four Days from their injury.
Who may be able to join
- Severe isolated TBI (GCS<8, AIS =<3), CT-verified TBI (tSDH,tEDH, tSAH, contusion bleedings) caused by blunt or penetrating trauma.
- Established intracranial monitoring (ICP, MD, LiCox pBtO2) at NICU.
- Age >= 18
- Time from trauma from 0 to 4 days.
- Informed consent from Close relative.
- Systemic hyperoxygenation can be used in patients with pBtO2 <20 mmHg, based on clinical decision.
Who cannot join
- Major extracranial injury, AIS >3
- Brain dead or expected survival <24 hours
- Pregnancy
- Respiratory insufficiency FiO2> 40%
- 6. No consent from relative.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska University Hospital
Stockholm, 17176
Michael Nekludov, MD PhD, michael.nekludov@regionstockholm.se
About this study
Official title: Formation of Reactive Oxygen Species in Patients With Severe Traumatic Brain Injury in Normal vs Increased Oxygenation.
This project an observational study performed on patients with severe Traumatic Brain Injury (TBI) treated at Neurosurgical ICU (NICU) at Karolinska University Hospital. The purpose of this study is to evaluate the effects of various oxygenation levels on production rate of Reactive Oxygen Species (ROS) in patients with severe traumatic brain injury (TBI). The patients will be included in the study after the placement of intracranial monitoring device consisting of intracranial pressure gage (Codman), microdialysis (MD), and Licox oxygen electrode for measurement of partial pressure of oxygen in brain tissue (pBtO2). Intracranial monitoring is inserted on clinical indications and is used for early detection of deleterious processes in brain tissue such as hypoxia or hypoperfusion and for purpose of guiding of given therapies such as cerebral perfusion pressure (CPP), oxygenation, dosage of vasoactive drugs etc. Despite the technical possibilities to monitor all these physiological parameters, there are no clear guidelines how to interpret the MD and pBtO2 data and implement it in clinical decision making. One of the controversies deals with optimization of oxygen levels: some authors point out the importance of adequate brain tissue oxygenation, whereas other researchers are worried about the possible negative effects of excessive oxygen levels such as increased production of ROS or facilitating pulmonary atelectasis, contributing to adverse outcome.
The purpose of this study is to investigate the effect of various oxygenation levels on ROS production in TBI patients.
This pilot study is designed to measure short-lived ROS in blood and microdialysis fluid samples of TBI patients during alternating periods of normal vs temporarily increased oxygenation levels under normobaric conditions (normal atmospheric pressure).
- Keywords
- TBI, ROS, oxygenation, cerebral monitoring, neurointensive care
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
ROS concentrations in blood
ROS concentrations in patient´s blood will be measured repeatedly at normal systemic oxygenation and at increased oxygenation if necessary.
Measured: 7 days
Markers of oxidative stress
Indirect markers of oxydative stress, as MDA (Malondialdehyde) and Isoprostane F2, in relation to level of systemic oxygenation.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study startNov 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Oxygenation vs ROS Formation in TBI PatientsStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101278
- Sponsor's protocol ID
- K2020-1148
- Acronym
- ROS-TBI
- Status last verified
- Apr 2022
- First submitted
- 6 Oct 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formation of Reactive Oxygen Species in Patients With Severe Traumatic Brain Injury in Normal vs Increased Oxygenation.
- ClinicalTrials.gov ID
- NCT05101278
- Acronym / sponsor ID
- ROS-TBI / K2020-1148
- Keywords
- TBI, ROS, oxygenation, cerebral monitoring, neurointensive care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- Nov 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Nov 2021 (actual)
- 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.
This project an observational study performed on patients with severe Traumatic Brain Injury (TBI) treated at Neurosurgical ICU (NICU) at Karolinska University Hospital. The purpose of this study is to evaluate the effects of various oxygenation levels on production rate of Reactive Oxygen Species (ROS) in patients with severe traumatic brain injury (TBI). The patients will be included in the study after the placement of intracranial monitoring device consisting of intracranial pressure gage (Codman), microdialysis (MD), and Licox oxygen electrode for measurement of partial pressure of oxygen in brain tissue (pBtO2). Intracranial monitoring is inserted on clinical indications and is used for early detection of deleterious processes in brain tissue such as hypoxia or hypoperfusion and for purpose of guiding of given therapies such as cerebral perfusion pressure (CPP), oxygenation, dosage of vasoactive drugs etc. Despite the technical possibilities to monitor all these physiological parameters, there are no clear guidelines how to interpret the MD and pBtO2 data and implement it in clinical decision making. One of the controversies deals with optimization of oxygen levels: some authors point out the importance of adequate brain tissue oxygenation, whereas other researchers are worried about the possible negative effects of excessive oxygen levels such as increased production of ROS or facilitating pulmonary atelectasis, contributing to adverse outcome.
The purpose of this study is to investigate the effect of various oxygenation levels on ROS production in TBI patients.
This pilot study is designed to measure short-lived ROS in blood and microdialysis fluid samples of TBI patients during alternating periods of normal vs temporarily increased oxygenation levels under normobaric conditions (normal atmospheric pressure).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with severe isolated TBI with established intracranial monitoring (based on clinical desision), inclusion between 0 to four Days from their injury.
Key inclusion criteria (6 listed)
- Severe isolated TBI (GCS<8, AIS =<3), CT-verified TBI (tSDH,tEDH, tSAH, contusion bleedings) caused by blunt or penetrating trauma.
- Established intracranial monitoring (ICP, MD, LiCox pBtO2) at NICU.
- Age >= 18
- Time from trauma from 0 to 4 days.
- Informed consent from Close relative.
Key exclusion criteria (5 listed)
- Major extracranial injury, AIS >3
- Brain dead or expected survival <24 hours
- Pregnancy
- Respiratory insufficiency FiO2> 40%
- 6. No consent from relative.
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
ROS concentrations in blood
Time frame: 7 days
ROS concentrations in patient´s blood will be measured repeatedly at normal systemic oxygenation and at increased oxygenation if necessary.
Markers of oxidative stress
Time frame: 7 days
Indirect markers of oxydative stress, as MDA (Malondialdehyde) and Isoprostane F2, in relation to level of systemic oxygenation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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 Systemic Oxygenation vs ROS Formation in TBI Patients, run by Region Stockholm at 1 site in Sweden.
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 6 inclusion and 5 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 28 Apr 2022. 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 Sweden. 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?
ROS concentrations in blood (time frame: 7 days). The study lists 2 primary outcomes in all. 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 28 Apr 2022.