Traumatic Brain InjuryNCT06423469
Noninvasive Intracranial Pressure Waveforms Assessment in Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Sergio Brasil, MD at 4 sites in Brazil.
Trial summary
In clinical practice, hospital admission of patients with altered level of consciousness ranging from drowsiness to decreasing response states or coma is extremely common. This clinical condition demands effective investigation and early treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Noninvasive ICP monitoring
- Type of treatment
- Medical device
- How many people
- 345 participants
- Where
- 4 sitesBrazil
- Study dates
- 1 Feb 2020to 30 Apr 2024
- How long will I take part?
- 6 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of any gender, older than 18 years, with very acute moderate or severe TBI will be included just after stabilization and any surgical evacuation procedure performed.
Who may be able to join
- Moderate to severe traumatic brain injury with less than 24 hours.
Who cannot join
- Primary decompressive craniectomy
- Brain death signs at admission
- Severe hemodynamic instability
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Hospital João XXIII
Belo Horizonte, Minas Gerais, 05403000
Hospital de Emergência e Trauma Senador Humberto Lucena
João Pessoa, Paraíba, 05403000
Universidade Federal do Amazonas
Manaus, Amazonas, 05403000
Universidade de São Paulo
São Paulo, São Paulo, 05403000
About this study
Official title: A Multicenter Observational Cohort for the Determination of Noninvasive Intracranial Pressure Waveforms Role in Traumatic Brain Injury
In clinical practice, hospital admission of patients with altered level of consciousness ranging from drowsiness to decreasing response states or coma is extremely common. This clinical condition demands effective investigation and early treatment. Imaging and laboratory tests have played increasingly relevant roles in supporting clinical research. One of the main causes of coma is intracranial hypertension (IH), with traumatic brain injuries (TBI) and cerebral hemorrhages being the major contributors to its development. IH increases the risk of secondary damage in these populations, and consequently, morbidity and mortality. Clinical studies show that adequate intracranial pressure (ICP) control in TBI patients reduces mortality and increases functionality. Unfortunately, the most accurate way to measure and evaluate the ICP is through a catheter located inside the skull, and its perforation is required for this purpose. Several studies have attempted to identify noninvasive solutions for ICP monitoring; however, to date, none of the techniques gathered sufficient evidence to replace invasive monitors. Recently, an extensometer device has been developed, which only maintains contact with the skull's skin and therefore eliminates the need for its perforation, being able to obtain recordings of cranial dilatation at each heartbeat and consequently reflecting brain compliance. In vivo studies have identified excellent qualitative correlation with catheter ICP recordings. However, this device was evaluated only in a limited number of clinical cohorts and the correlations between the information provided by this device with patients outcomes is still poor. Therefore, this project aims primarily to evaluate the use of this noninvasive brain compliance monitoring system in a cohort of TBI patients.
- Conditions
- Traumatic Brain Injury
- Being tested
- Noninvasive ICP monitoring
- Keywords
- traumatic brain injury, intracranial pressure, intracranial compliance, intracranial pressure waveforms, neurological noninvasive monitoring
- 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.
Noninvasive ICP monitoringDevice
The brain4care system is a FDA approved noninvasive device for surrogate intracranial pressure monitoring. Serial monitoring sessions were performed in included patients. Information recorded was for study purposes only and did not affect any therapy planned for the attending teams.
| Study group | Role | What they receive |
|---|---|---|
| TBI patients | TBI patients to be monitored daily with the brain4care system for fifteen days Receives: Device: Noninvasive ICP monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Is in-hospital mortality correlated with poorer brain4care biometrics?
Measured: One month
Secondary outcomes (1)
Morbidity
Is morbidity correlated with poorer brain4care biometrics?
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Feb 2020
- Primary completion30 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 345 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sergio Brasil, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Braincare USA Corp
- Responsible party
- Sponsor-investigator, Sergio Brasil, MD, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423469
- Sponsor's protocol ID
- 39348920.1.1001.0068
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Possibly some anonymous data can be shared with other researchers upon reasonable request.
Publications
Gulamali F, Jayaraman P, Sawant AS, Desman J, Fox B, Chang A, Soong BY, Arivazaghan N, Reynolds AS, Duong SQ, Vaid A, Kovatch P, Freeman R, Hofer IS, Sakhuja A, Dangayach NS, Reich DS, Charney AW, Nadkarni GN. Derivation, External Validation and Clinical Implications of a deep learning approach for intracranial pressure estimation using non-cranial waveform measurements. medRxiv [Preprint]. 2024 Jan 30:2024.01.30.24301974. doi: 10.1101/2024.01.30.24301974.
PubMed 38352556Kawoos U, McCarron RM, Auker CR, Chavko M. Advances in Intracranial Pressure Monitoring and Its Significance in Managing Traumatic Brain Injury. Int J Mol Sci. 2015 Dec 4;16(12):28979-97. doi: 10.3390/ijms161226146.
PubMed 26690122de Moraes FM, Rocha E, Barros FCD, Freitas FGR, Miranda M, Valiente RA, de Andrade JBC, Neto FEAC, Silva GS. Waveform Morphology as a Surrogate for ICP Monitoring: A Comparison Between an Invasive and a Noninvasive Method. Neurocrit Care. 2022 Aug;37(1):219-227. doi: 10.1007/s12028-022-01477-4. Epub 2022 Mar 24.
PubMed 35332426de Moraes FM, Brasil S, Frigieri G, Robba C, Paiva W, Silva GS. ICP wave morphology as a screening test to exclude intracranial hypertension in brain-injured patients: a non-invasive perspective. J Clin Monit Comput. 2024 Aug;38(4):773-782. doi: 10.1007/s10877-023-01120-3. Epub 2024 Feb 14.
PubMed 38355918Brasil S, Solla DJF, Nogueira RC, Teixeira MJ, Malbouisson LMS, Paiva WDS. A Novel Noninvasive Technique for Intracranial Pressure Waveform Monitoring in Critical Care. J Pers Med. 2021 Dec 5;11(12):1302. doi: 10.3390/jpm11121302.
PubMed 34945774
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Observational Cohort for the Determination of Noninvasive Intracranial Pressure Waveforms Role in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06423469
- Acronym / sponsor ID
- 39348920.1.1001.0068
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, intracranial pressure, intracranial compliance, intracranial pressure waveforms, neurological noninvasive monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Sergio Brasil, MDUniversity, hospital or other
- Collaborators
- Braincare USA Corp
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 21 May 2024 (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.
In clinical practice, hospital admission of patients with altered level of consciousness ranging from drowsiness to decreasing response states or coma is extremely common. This clinical condition demands effective investigation and early treatment. Imaging and laboratory tests have played increasingly relevant roles in supporting clinical research. One of the main causes of coma is intracranial hypertension (IH), with traumatic brain injuries (TBI) and cerebral hemorrhages being the major contributors to its development. IH increases the risk of secondary damage in these populations, and consequently, morbidity and mortality. Clinical studies show that adequate intracranial pressure (ICP) control in TBI patients reduces mortality and increases functionality. Unfortunately, the most accurate way to measure and evaluate the ICP is through a catheter located inside the skull, and its perforation is required for this purpose. Several studies have attempted to identify noninvasive solutions for ICP monitoring; however, to date, none of the techniques gathered sufficient evidence to replace invasive monitors. Recently, an extensometer device has been developed, which only maintains contact with the skull's skin and therefore eliminates the need for its perforation, being able to obtain recordings of cranial dilatation at each heartbeat and consequently reflecting brain compliance. In vivo studies have identified excellent qualitative correlation with catheter ICP recordings. However, this device was evaluated only in a limited number of clinical cohorts and the correlations between the information provided by this device with patients outcomes is still poor. Therefore, this project aims primarily to evaluate the use of this noninvasive brain compliance monitoring system in a cohort of TBI patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TBI patients | – | Device: Noninvasive ICP monitoringTBI patients to be monitored daily with the brain4care system for fifteen days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of any gender, older than 18 years, with very acute moderate or severe TBI will be included just after stabilization and any surgical evacuation procedure performed.
Key inclusion criteria (1 listed)
- Moderate to severe traumatic brain injury with less than 24 hours.
Key exclusion criteria (3 listed)
- Primary decompressive craniectomy
- Brain death signs at admission
- Severe hemodynamic instability
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 |
|---|---|---|
| Noninvasive ICP monitoringThe brain4care system is a FDA approved noninvasive device for surrogate intracranial pressure monitoring. Serial monitoring sessions were performed in included patients. Information recorded was for study purposes only and did not affect any therapy planned for the attending teams. | Device | TBI patients |
Primary outcome
In-hospital mortality
Time frame: One month
Is in-hospital mortality correlated with poorer brain4care biometrics?
1 secondary outcome
Morbidity
Time frame: Six months
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 21 May 2024.
- Background: PubMed 38352556Gulamali F, Jayaraman P, Sawant AS, Desman J, Fox B, Chang A, Soong BY, Arivazaghan N, Reynolds AS, Duong SQ, Vaid A, Kovatch P, Freeman R, Hofer IS, Sakhuja A, Dangayach NS, Reich DS, Charney AW, Nadkarni GN. Derivation, External Validation and Clinical Implications of a deep learning approach for intracranial pressure estimation using non-cranial waveform measurements. medRxiv [Preprint]. 2024 Jan 30:2024.01.30.24301974. doi: 10.1101/2024.01.30.24301974.
- Background: PubMed 26690122Kawoos U, McCarron RM, Auker CR, Chavko M. Advances in Intracranial Pressure Monitoring and Its Significance in Managing Traumatic Brain Injury. Int J Mol Sci. 2015 Dec 4;16(12):28979-97. doi: 10.3390/ijms161226146.
- Background: PubMed 35332426de Moraes FM, Rocha E, Barros FCD, Freitas FGR, Miranda M, Valiente RA, de Andrade JBC, Neto FEAC, Silva GS. Waveform Morphology as a Surrogate for ICP Monitoring: A Comparison Between an Invasive and a Noninvasive Method. Neurocrit Care. 2022 Aug;37(1):219-227. doi: 10.1007/s12028-022-01477-4. Epub 2022 Mar 24.
- Background: PubMed 38355918de Moraes FM, Brasil S, Frigieri G, Robba C, Paiva W, Silva GS. ICP wave morphology as a screening test to exclude intracranial hypertension in brain-injured patients: a non-invasive perspective. J Clin Monit Comput. 2024 Aug;38(4):773-782. doi: 10.1007/s10877-023-01120-3. Epub 2024 Feb 14.
- Background: PubMed 34945774Brasil S, Solla DJF, Nogueira RC, Teixeira MJ, Malbouisson LMS, Paiva WDS. A Novel Noninvasive Technique for Intracranial Pressure Waveform Monitoring in Critical Care. J Pers Med. 2021 Dec 5;11(12):1302. doi: 10.3390/jpm11121302.
- Individual participant dataSharing planned: Undecided. Possibly some anonymous data can be shared with other researchers upon reasonable request.
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites 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 Sergio Brasil, MD at 4 sites in Brazil.
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 1 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: finished, as of the sponsor's last update on 21 May 2024. 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 Brazil. 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?
In-hospital mortality (time frame: One month). 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 NCT06423469, which also lists 5 linked publications.
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 21 May 2024.