Traumatic Brain InjuryNCT05387018
The Effects of Hyperbaric Oxygen on Non-acute Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Traumatic brain injury (TBI) continues to be a major cause of death and disability throughout the world. The reduced cerebral blood flow secondary to the direct trauma-induced damage deregulates cerebral metabolism and depletes energy stores within the brain. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2022to 5 Feb 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had been hospitalized for rehabilitation in our rehabilitation unit after traumatic brain injury, to study the differences in outcomes between those who received hyperbaric oxygen therapy within 3 months of injury and those who did not
Who may be able to join
- The age ranges from 18 to 90
- Traumatic brain injury, Head CT scan confirmed the presence of at least one of the following findings: Intracranial hemorrhage, subdural hematoma, epidural hematoma, brain contusion, hemorrhagic brain contusion, subarachnoid hemorrhage, brain stem injury
- Those who had good compliance, signed informed consent and were eligible for inclusion according to the investigator's judgment.
Who cannot join
- Penetrating head injury
- Combined with spinal cord injury or peripheral nerve injury
- Severe coagulopathy
- Severe heart function, liver function, kidney function and other organ function abnormality
- The investigator considers the subject to be at potential risk or to have any other factors that may interfere with the subject
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Traumatic brain injury (TBI) continues to be a major cause of death and disability throughout the world. The reduced cerebral blood flow secondary to the direct trauma-induced damage deregulates cerebral metabolism and depletes energy stores within the brain. Diffusion barriers to the cellular delivery of oxygen develop and persist. Besides, TBI often leads to intracranial hypertension, which in turn exacerbates diffusion disorders, further reducing cerebral oxygenation, and deteriorates the injury. By increasing the partial pressure of oxygen in blood, reducing intracranial pressure and cerebral edema, Hyperbaric oxygen therapy (HBO2) has been used in early treatment of TBI. However, due to the different severity of TBI, the clinical situation of early insult is complex and unpredictable, ordinarily there was a time delay between TBI and onset of HBO2 treatment averaging more than 2 weeks, especially in patients with severe TBI. Whether the delayed intervention is still effective is controversial.
Read the detailed description
Traumatic brain injury (TBI) continues to be a major cause of death and disability throughout the world. The pathophysiological processes which occur post-TBI are complex and have not been fully elucidated. Penetrating injury, mechanical stress, cceleration-deceleration injury, and shear forces provide the direct trauma-induced damage. Subsequently, the reduced cerebral blood flow deregulates cerebral metabolism and depletes energy stores within the brain. Diffusion barriers to the cellular delivery of oxygen develop and persist. Besides, TBI often leads to intracranial hypertension, which in turn exacerbates diffusion disorders, further reducing cerebral oxygenation, and deteriorates the injury. Ischemia has been implicated as a major cause of secondary brain injury and death following severe brain injury.
Hyperbaric oxygen therapy (HBO2) has been used in early treatment of TBI. Studies have shown that increased tissue oxygen delivery is capable of driving an increase in oxygen utilization, leading to improved cerebral aerobic metabolism. By increasing the partial pressure of oxygen in blood, HBO2 increases cerebral oxygen saturation. In addition, HBO2 has been shown in both experimental and clinical studies to reduce intracranial pressure and cerebral edema after severe TBI. HBO2 has been shown to decrease mortality rates and improve functional outcome in severely brain-injured patients.
However, due to the different severity of TBI, the clinical situation of early insult is complex and diverse, and a considerable number of patients in the acute stage was accompanied by unstable intracranial hemorrhage, hemodynamic instability, ventilator assisted ventilation and other unpredictable conditions, therefore, ordinarily there was a time delay between TBI and onset of HBO2 treatment averaging more than 2 weeks, especially in patients with severe TBI. Whether the delayed intervention is still effective is controversial.
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, hyperbaric oxygen, non-acute
- 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 |
|---|---|---|
| Observation group (hyperbaric oxygen + routine rehabilitation treatment) | no special intervention | |
| control group (routine rehabilitation treatment) | no special intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability Rating Scale, DRS
Different points of DRS represent the degree of disability: 0 point : No; 1 point: Mild; 2-3 points: Partial; 4-6 points: Obvious; 7-11 points: Moderately severe; 12 to 16 points: Severe; 17-21 points: Extremely severe; 22-24: Vegetative state; 25-29 points: Extreme vegetative state; 30: Death
Measured: 2014-2024
Glasgow Outcome Scale-Extend
The GOSE measures overall disability (independence, work, social and leisure activities, family and friendship and return to normal life) after TBI and divides patients into the following outcome categories:
1= dead; 2 = vegetative state (VS); 3 = lower severe disability and complete dependence on others (Lower SD); 4 = upper severe disability and some dependency on others, but can be alone (on their own ) for 8 hours (Upper SD); 5= lower moderate disability, living independently, (not working or) working at a lower level of performance/sheltered work (Lower MD); 6 = upper moderate disability and returning to previous work with adjustments (Upper MD); 7 = lower good recovery with (almost back at full functional recovery) only minor physical or mental deficits (minor disability) (Lower GR);8 = upper good recoverythat implies full functional recovery (without any disability) (Upper GR)
Measured: 2014-2024
Secondary outcomes (2)
Glasgow Outcome Scale, GOS
The Glasgow Outcome Scale was divided into five scales, with poor prognosis at scales 1 to 3 and good prognosis at scales 4 to 5
Measured: 2014-2024
Functional Independence Measure （FIM）
The FIM is composed of 18 items designed to operationally measure functional independence in self-care (eg, toileting), mobility (eg, walking, transfers), and cognition (eg, memory, communication, problem solving). Higher scores represent a greater level of independence.
Measured: 2014-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start31 Mar 2022
- Primary completion5 Feb 2025
- Study completion5 Feb 2025
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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bing Xiong, master, Principal investigator, director of department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387018
- Sponsor's protocol ID
- 2022-0031
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2022
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Z, Li Z, Li S, Xiong B, Zhou Y, Shi C. Hyperbaric oxygen for moderate-to-severe traumatic brain injury: outcomes 5-8 years after injury. Med Gas Res. 2025 Mar 1;15(1):156-163. doi: 10.4103/mgr.MEDGASRES-D-24-00018. Epub 2024 Sep 25.
PubMed 39324933
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hyperbaric Oxygen on Non-acute Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05387018
- Acronym / sponsor ID
- 2022-0031
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, hyperbaric oxygen, non-acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 24 May 2022 (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.
Traumatic brain injury (TBI) continues to be a major cause of death and disability throughout the world. The reduced cerebral blood flow secondary to the direct trauma-induced damage deregulates cerebral metabolism and depletes energy stores within the brain. Diffusion barriers to the cellular delivery of oxygen develop and persist. Besides, TBI often leads to intracranial hypertension, which in turn exacerbates diffusion disorders, further reducing cerebral oxygenation, and deteriorates the injury. By increasing the partial pressure of oxygen in blood, reducing intracranial pressure and cerebral edema, Hyperbaric oxygen therapy (HBO2) has been used in early treatment of TBI. However, due to the different severity of TBI, the clinical situation of early insult is complex and unpredictable, ordinarily there was a time delay between TBI and onset of HBO2 treatment averaging more than 2 weeks, especially in patients with severe TBI. Whether the delayed intervention is still effective is controversial.
Detailed description
Traumatic brain injury (TBI) continues to be a major cause of death and disability throughout the world. The pathophysiological processes which occur post-TBI are complex and have not been fully elucidated. Penetrating injury, mechanical stress, cceleration-deceleration injury, and shear forces provide the direct trauma-induced damage. Subsequently, the reduced cerebral blood flow deregulates cerebral metabolism and depletes energy stores within the brain. Diffusion barriers to the cellular delivery of oxygen develop and persist. Besides, TBI often leads to intracranial hypertension, which in turn exacerbates diffusion disorders, further reducing cerebral oxygenation, and deteriorates the injury. Ischemia has been implicated as a major cause of secondary brain injury and death following severe brain injury.
Hyperbaric oxygen therapy (HBO2) has been used in early treatment of TBI. Studies have shown that increased tissue oxygen delivery is capable of driving an increase in oxygen utilization, leading to improved cerebral aerobic metabolism. By increasing the partial pressure of oxygen in blood, HBO2 increases cerebral oxygen saturation. In addition, HBO2 has been shown in both experimental and clinical studies to reduce intracranial pressure and cerebral edema after severe TBI. HBO2 has been shown to decrease mortality rates and improve functional outcome in severely brain-injured patients.
However, due to the different severity of TBI, the clinical situation of early insult is complex and diverse, and a considerable number of patients in the acute stage was accompanied by unstable intracranial hemorrhage, hemodynamic instability, ventilator assisted ventilation and other unpredictable conditions, therefore, ordinarily there was a time delay between TBI and onset of HBO2 treatment averaging more than 2 weeks, especially in patients with severe TBI. Whether the delayed intervention is still effective is controversial.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation group (hyperbaric oxygen + routine rehabilitation treatment) | – | –no special intervention |
| control group (routine rehabilitation treatment) | – | –no special intervention |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had been hospitalized for rehabilitation in our rehabilitation unit after traumatic brain injury, to study the differences in outcomes between those who received hyperbaric oxygen therapy within 3 months of injury and those who did not
Key inclusion criteria (3 listed)
- The age ranges from 18 to 90
- Traumatic brain injury, Head CT scan confirmed the presence of at least one of the following findings: Intracranial hemorrhage, subdural hematoma, epidural hematoma, brain contusion, hemorrhagic brain contusion, subarachnoid hemorrhage, brain stem injury
- Those who had good compliance, signed informed consent and were eligible for inclusion according to the investigator's judgment.
Key exclusion criteria (5 listed)
- Penetrating head injury
- Combined with spinal cord injury or peripheral nerve injury
- Severe coagulopathy
- Severe heart function, liver function, kidney function and other organ function abnormality
- The investigator considers the subject to be at potential risk or to have any other factors that may interfere with the subject
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
Disability Rating Scale, DRS
Time frame: 2014-2024
Different points of DRS represent the degree of disability: 0 point : No; 1 point: Mild; 2-3 points: Partial; 4-6 points: Obvious; 7-11 points: Moderately severe; 12 to 16 points: Severe; 17-21 points: Extremely severe; 22-24: Vegetative state; 25-29 points: Extreme vegetative state; 30: Death
Glasgow Outcome Scale-Extend
Time frame: 2014-2024
The GOSE measures overall disability (independence, work, social and leisure activities, family and friendship and return to normal life) after TBI and divides patients into the following outcome categories: 1= dead; 2 = vegetative state (VS); 3 = lower severe disability and complete dependence on others (Lower SD); 4 = upper severe disability and some dependency on others, but can be alone (on their own ) for 8 hours (Upper SD); 5= lower moderate disability, living independently, (not working or) working at a lower level of performance/sheltered work (Lower MD); 6 = upper moderate disability and returning to previous work with adjustments (Upper MD); 7 = lower good recovery with (almost back at full functional recovery) only minor physical or mental deficits (minor disability) (Lower GR);8 = upper good recoverythat implies full functional recovery (without any disability) (Upper GR)
2 secondary outcomes
Glasgow Outcome Scale, GOS
Time frame: 2014-2024
Functional Independence Measure （FIM）
Time frame: 2014-2024
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 10 Feb 2025.
- Derived from this study: PubMed 39324933Zhang Z, Li Z, Li S, Xiong B, Zhou Y, Shi C. Hyperbaric oxygen for moderate-to-severe traumatic brain injury: outcomes 5-8 years after injury. Med Gas Res. 2025 Mar 1;15(1):156-163. doi: 10.4103/mgr.MEDGASRES-D-24-00018. Epub 2024 Sep 25.
- Individual participant dataSharing planned: No
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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.
Bing Xiong, master principal investigator
director of department
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 Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 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: finished, as of the sponsor's last update on 10 Feb 2025. 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 China. 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.
What does the primary outcome measure?
Disability Rating Scale, DRS (time frame: 2014-2024). 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?
On the ClinicalTrials.gov record for NCT05387018, 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 10 Feb 2025.