Traumatic Brain Injury (TBI)PROMPTNCT07538440
Prognostic Model for Predicting Outcome After Moderate to Severe Paediatric Traumatic Brain Injury
An observational study of Traumatic Brain Injury (TBI), run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Due to ethical and logistical challenges related to paediatric research, there is limited age-appropriate evidence for managing paediatric traumatic brain injury (pTBI). The prognostic models used for adult TBI research (IMPACT, CRASH), have been derived and validated from analysis of large international datasets… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Traumatic Brain Injury (TBI)
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2025to 31 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The existing datasets of paediatric patients with moderate to severe TBI will be combined and prediction model will be developed using the baseline injury severity variables with training and validation groups.
Who may be able to join
- Patients admitted to hospital with moderate to severe TBI
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction Model in Paediatric Moderate to Severe TBI
Due to ethical and logistical challenges related to paediatric research, there is limited age-appropriate evidence for managing paediatric traumatic brain injury (pTBI). The prognostic models used for adult TBI research (IMPACT, CRASH), have been derived and validated from analysis of large international datasets which have undergone further validation in multiple prospective studies; the wide use of these prognostic models across neurotrauma research highlights the relative simplicity and the variables used for prediction making them applicable to both low and high resource set-ups. This has facilitated international collaborative research in adult TBI. At present, no such models exist for pTBI with most paediatric research continuing to use adult prognostic models.
Though the variables used for these models show association with outcome in pTBI as well, there are multiple issues with this approach with the key difficulty being that younger age is expected to be associated with better outcome in these models; however, the balance between neuroplasticity and neurodevelopmental trajectory in children is difficult to predict with evidence suggesting worse neuro-developmental outcomes after TBI in younger children. Hence the adult models can either over- or under-predict neurological outcomes in pTBI and have never been validated in pTBI datasets.
Given that the amount of data required to create pTBI predictive model is difficult to collect and reasonable validity of adult prognostic models in pTBI, investigators propose to create paediatric modification to the adult models and identify a robust pTBI predictive model for improved classification of injury severity to predict disease trajectory and outcome as well as stratification of patients for interventional research and benchmarking in pTBI to help with appropriate resource allocation for neuro-interventions towards improved outcomes. This will help identify age-appropriate benchmarks for pTBI research studies as well as complement an individual child's clinical assessment, treatment decisions, informing families and resource allocation.
Read the detailed description
- Background The healthcare, societal and economic impact from paediatric traumatic brain injury (pTBI) is one of the greatest unmet needs with estimates suggesting upto 2/3rd of survivors developing life-long neurological deficits. Due to ethical and logistical challenges related to paediatric research, there is limited age-appropriate evidence for children which perpetuates the funding gaps further confounding the lack of evidence. However, extrapolation of adult TBI research evidence to children is inaccurate and inappropriate given the differences in mechanisms and patterns of injury, pathophysiological responses and neurological recovery from it, in the context of developmental trajectory; hence, robust evidence is required to improve outcomes from pTBI as well as facilitate research collaborations. The prognostic models used for adult TBI research (IMPACT, CRASH)5,6 and imaging criteria (Marshall and Rotterdam scores), have been derived and validated from analysis of large international datasets which have undergone further validation in multiple prospective studies; the wide use of these prognostic models across neurotrauma research highlights the relative simplicity and the variables used for prediction making them applicable to both low and high resource set-ups. This has facilitated international collaborative research in adult TBI; however, no such models exist for pTBI with most pTBI research continuing to use adult prognostic models. Though the variables used for these models show association with outcome in pTBI as well, there are multiple issues with this approach with the key difficulty being the age variable. In the adult models, the younger age is expected to be associated with better outcome; for CRASH, the model is likely weighed heavily towards non-age variables as the younger patients are expected to do better with patients between 18-40 lumped as <40 years and for IMPACT, slightly better which accounts for 14 years and above. However, the balance between neuroplasticity and neurodevelopmental trajectory in paediatric age group is difficult to predict with evidence suggesting worse neuro-developmental outcomes after TBI in younger children. Hence the adult models can either over- or under-predict neurological outcomes in pTBI and have never been validated in pTBI datasets.
- Rationale \& Theoretical Framework A validated predictive model for pTBI would be the first step towards collaborative research and identifying age-appropriate benchmarks for pTBI research studies as well as to complement an individual child's clinical assessment, treatment decisions, informing families and resource allocation. Given that the amount of data required to create pTBI predictive model is difficult to collect and the reasonable validity of adult prognostic models in pTBI, albeit in small single-centre studies, investigators propose to create paediatric modification to the adult models and identify a robust pTBI predictive model for improved classification of injury severity to predict disease trajectory and outcome as well as stratification of patients for interventional research and benchmarking in pTBI to help with appropriate resource allocation for neuro-interventions towards improved outcomes.
- Research Question/Aims and Objectives: To create and validate a paediatric specific prognostic model for outcomes following moderate to severe TBI for use in both resource-limited and resource-rich environments. The study hypothesis is that the performance of the current adult TBI prognostic models in predicting outcomes following pTBI can be improved by introducing age-appropriate modifications to the existing models.
- Study Design/ Methods: The study will use combined retrospective pTBI datasets (moderate to severe TBI in children < 18 years).
- Sample \& Statistical Methods:
There is no defined sample size for the study. Investigators aim to collect datasets which contain the variables defining injury severity from children with moderate to severe TBI upto the age of 18 years. There are no exclusion criteria for the study. All the datasets will either be from a prospective study (ethics approved with valid consent) and/or datasets created for audit/institutional purposes with appropriate approvals from local/national research committees and contain anonymised non-identifiable information.
- Conditions
- Traumatic Brain Injury (TBI)
- Keywords
- Paediatric, Prediction modelling, Outcome
- 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 |
|---|---|---|
| ADAPT | International Paediatric severe traumatic brain injury prospective study- 1000 patients | |
| STARSHIP | Prospective multicentre researchdatabase of Paediatric moderate to severe TBI of 135 patients | |
| CENTER-TBI | Prospective research database of traumatic brain injury, 227 patients <18 years of age. | |
| Cambridge | Database of Paediatric TBI admissions to CUH, 350 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Score.
The scale ranges from 1 to 5 with increasing scores suggesting improving outcome (1-death, 5-normal). The score will be dichotomised to favourable (4-5) and unfavourable (1-3).
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 posted20 Apr 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain Injury (TBI)Studies 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
- Other
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht
- Responsible party
- Principal investigator, Shruti Agrawal, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538440
- Sponsor's protocol ID
- A097348
- Acronym
- PROMPT
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As per the data share agreement with existing datasets, the combined dataset will only be used for the prediction modelling. However, the individual dataset controllers maybe willing to consider valid scientific requests as per their arrangements
Publications
Steyerberg EW, Harrell FE Jr. Prediction models need appropriate internal, internal-external, and external validation. J Clin Epidemiol. 2016 Jan;69:245-7. doi: 10.1016/j.jclinepi.2015.04.005. Epub 2015 Apr 18. No abstract available.
PubMed 25981519Huth SF, Slater A, Waak M, Barlow K, Raman S. Predicting Neurological Recovery after Traumatic Brain Injury in Children: A Systematic Review of Prognostic Models. J Neurotrauma. 2020 Oct 15;37(20):2141-2149. doi: 10.1089/neu.2020.7158. Epub 2020 Jul 20.
PubMed 32460675Young AM, Guilfoyle MR, Fernandes H, Garnett MR, Agrawal S, Hutchinson PJ. The application of adult traumatic brain injury models in a pediatric cohort. J Neurosurg Pediatr. 2016 Nov;18(5):558-564. doi: 10.3171/2016.5.PEDS15427. Epub 2016 Aug 26.
PubMed 27564785Yue JK, Lee YM, Sun X, van Essen TA, Elguindy MM, Belton PJ, Pisica D, Mikolic A, Deng H, Kanter JH, McCrea MA, Bodien YG, Satris GG, Wong JC, Ambati VS, Grandhi R, Puccio AM, Mukherjee P, Valadka AB, Tarapore PE, Huang MC, DiGiorgio AM, Markowitz AJ, Yuh EL, Okonkwo DO, Steyerberg EW, Lingsma HF, Menon DK, Maas AIR, Jain S, Manley GT; The TRACK-TBI Investigators. Performance of the IMPACT and CRASH prognostic models for traumatic brain injury in a contemporary multicenter cohort: a TRACK-TBI study. J Neurosurg. 2024 Mar 15;141(2):417-429. doi: 10.3171/2023.11.JNS231425. Print 2024 Aug 1.
PubMed 38489823Maas AI, Hukkelhoven CW, Marshall LF, Steyerberg EW. Prediction of outcome in traumatic brain injury with computed tomographic characteristics: a comparison between the computed tomographic classification and combinations of computed tomographic predictors. Neurosurgery. 2005 Dec;57(6):1173-82; discussion 1173-82. doi: 10.1227/01.neu.0000186013.63046.6b.
PubMed 16331165Martin FP, Goronflot T, Moyer JD, Huet O, Asehnoune K, Cinotti R, Gourraud PA, Roquilly A. Predictive Models of Long-Term Outcome in Patients with Moderate to Severe Traumatic Brain Injury are Biased Toward Mortality Prediction. Neurocrit Care. 2025 Apr;42(2):573-586. doi: 10.1007/s12028-024-02082-3. Epub 2024 Aug 13.
PubMed 39138720Sta Maria NS, Sargolzaei S, Prins ML, Dennis EL, Asarnow RF, Hovda DA, Harris NG, Giza CC. Bridging the gap: Mechanisms of plasticity and repair after pediatric TBI. Exp Neurol. 2019 Aug;318:78-91. doi: 10.1016/j.expneurol.2019.04.016. Epub 2019 May 2.
PubMed 31055004Speer EM, Lee LK, Bourgeois FT, Gitterman D, Hay WW Jr, Davis JM, Javier JR. The state and future of pediatric research-an introductory overview : The state and future of pediatric research series. Pediatr Res. 2023 Jan 24:1-5. doi: 10.1038/s41390-022-02439-4. Online ahead of print.
PubMed 36694026Dewan MC, Mummareddy N, Wellons JC 3rd, Bonfield CM. Epidemiology of Global Pediatric Traumatic Brain Injury: Qualitative Review. World Neurosurg. 2016 Jul;91:497-509.e1. doi: 10.1016/j.wneu.2016.03.045. Epub 2016 Mar 25.
PubMed 27018009
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model in Paediatric Moderate to Severe TBI
- ClinicalTrials.gov ID
- NCT07538440
- Acronym / sponsor ID
- PROMPT / A097348
- Conditions
- Traumatic Brain Injury (TBI)
- Keywords
- Paediatric, Prediction modelling, Outcome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- UMC Utrecht
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Apr 2026 (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.
Due to ethical and logistical challenges related to paediatric research, there is limited age-appropriate evidence for managing paediatric traumatic brain injury (pTBI). The prognostic models used for adult TBI research (IMPACT, CRASH), have been derived and validated from analysis of large international datasets which have undergone further validation in multiple prospective studies; the wide use of these prognostic models across neurotrauma research highlights the relative simplicity and the variables used for prediction making them applicable to both low and high resource set-ups. This has facilitated international collaborative research in adult TBI. At present, no such models exist for pTBI with most paediatric research continuing to use adult prognostic models.
Though the variables used for these models show association with outcome in pTBI as well, there are multiple issues with this approach with the key difficulty being that younger age is expected to be associated with better outcome in these models; however, the balance between neuroplasticity and neurodevelopmental trajectory in children is difficult to predict with evidence suggesting worse neuro-developmental outcomes after TBI in younger children. Hence the adult models can either over- or under-predict neurological outcomes in pTBI and have never been validated in pTBI datasets.
Given that the amount of data required to create pTBI predictive model is difficult to collect and reasonable validity of adult prognostic models in pTBI, investigators propose to create paediatric modification to the adult models and identify a robust pTBI predictive model for improved classification of injury severity to predict disease trajectory and outcome as well as stratification of patients for interventional research and benchmarking in pTBI to help with appropriate resource allocation for neuro-interventions towards improved outcomes. This will help identify age-appropriate benchmarks for pTBI research studies as well as complement an individual child's clinical assessment, treatment decisions, informing families and resource allocation.
Detailed description
- Background The healthcare, societal and economic impact from paediatric traumatic brain injury (pTBI) is one of the greatest unmet needs with estimates suggesting upto 2/3rd of survivors developing life-long neurological deficits. Due to ethical and logistical challenges related to paediatric research, there is limited age-appropriate evidence for children which perpetuates the funding gaps further confounding the lack of evidence. However, extrapolation of adult TBI research evidence to children is inaccurate and inappropriate given the differences in mechanisms and patterns of injury, pathophysiological responses and neurological recovery from it, in the context of developmental trajectory; hence, robust evidence is required to improve outcomes from pTBI as well as facilitate research collaborations. The prognostic models used for adult TBI research (IMPACT, CRASH)5,6 and imaging criteria (Marshall and Rotterdam scores), have been derived and validated from analysis of large international datasets which have undergone further validation in multiple prospective studies; the wide use of these prognostic models across neurotrauma research highlights the relative simplicity and the variables used for prediction making them applicable to both low and high resource set-ups. This has facilitated international collaborative research in adult TBI; however, no such models exist for pTBI with most pTBI research continuing to use adult prognostic models. Though the variables used for these models show association with outcome in pTBI as well, there are multiple issues with this approach with the key difficulty being the age variable. In the adult models, the younger age is expected to be associated with better outcome; for CRASH, the model is likely weighed heavily towards non-age variables as the younger patients are expected to do better with patients between 18-40 lumped as <40 years and for IMPACT, slightly better which accounts for 14 years and above. However, the balance between neuroplasticity and neurodevelopmental trajectory in paediatric age group is difficult to predict with evidence suggesting worse neuro-developmental outcomes after TBI in younger children. Hence the adult models can either over- or under-predict neurological outcomes in pTBI and have never been validated in pTBI datasets.
- Rationale \& Theoretical Framework A validated predictive model for pTBI would be the first step towards collaborative research and identifying age-appropriate benchmarks for pTBI research studies as well as to complement an individual child's clinical assessment, treatment decisions, informing families and resource allocation. Given that the amount of data required to create pTBI predictive model is difficult to collect and the reasonable validity of adult prognostic models in pTBI, albeit in small single-centre studies, investigators propose to create paediatric modification to the adult models and identify a robust pTBI predictive model for improved classification of injury severity to predict disease trajectory and outcome as well as stratification of patients for interventional research and benchmarking in pTBI to help with appropriate resource allocation for neuro-interventions towards improved outcomes.
- Research Question/Aims and Objectives: To create and validate a paediatric specific prognostic model for outcomes following moderate to severe TBI for use in both resource-limited and resource-rich environments. The study hypothesis is that the performance of the current adult TBI prognostic models in predicting outcomes following pTBI can be improved by introducing age-appropriate modifications to the existing models.
- Study Design/ Methods: The study will use combined retrospective pTBI datasets (moderate to severe TBI in children < 18 years).
- Sample \& Statistical Methods:
There is no defined sample size for the study. Investigators aim to collect datasets which contain the variables defining injury severity from children with moderate to severe TBI upto the age of 18 years. There are no exclusion criteria for the study. All the datasets will either be from a prospective study (ethics approved with valid consent) and/or datasets created for audit/institutional purposes with appropriate approvals from local/national research committees and contain anonymised non-identifiable information.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ADAPT | – | –International Paediatric severe traumatic brain injury prospective study- 1000 patients |
| STARSHIP | – | –Prospective multicentre researchdatabase of Paediatric moderate to severe TBI of 135 patients |
| CENTER-TBI | – | –Prospective research database of traumatic brain injury, 227 patients <18 years of age. |
| Cambridge | – | –Database of Paediatric TBI admissions to CUH, 350 patients |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The existing datasets of paediatric patients with moderate to severe TBI will be combined and prediction model will be developed using the baseline injury severity variables with training and validation groups.
Key inclusion criteria (1 listed)
- Patients admitted to hospital with moderate to severe TBI
Key exclusion criteria (1 listed)
- None
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
Glasgow Outcome Score.
Time frame: 6 months
The scale ranges from 1 to 5 with increasing scores suggesting improving outcome (1-death, 5-normal). The score will be dichotomised to favourable (4-5) and unfavourable (1-3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 25981519Steyerberg EW, Harrell FE Jr. Prediction models need appropriate internal, internal-external, and external validation. J Clin Epidemiol. 2016 Jan;69:245-7. doi: 10.1016/j.jclinepi.2015.04.005. Epub 2015 Apr 18. No abstract available.
- Background: PubMed 32460675Huth SF, Slater A, Waak M, Barlow K, Raman S. Predicting Neurological Recovery after Traumatic Brain Injury in Children: A Systematic Review of Prognostic Models. J Neurotrauma. 2020 Oct 15;37(20):2141-2149. doi: 10.1089/neu.2020.7158. Epub 2020 Jul 20.
- Background: PubMed 27564785Young AM, Guilfoyle MR, Fernandes H, Garnett MR, Agrawal S, Hutchinson PJ. The application of adult traumatic brain injury models in a pediatric cohort. J Neurosurg Pediatr. 2016 Nov;18(5):558-564. doi: 10.3171/2016.5.PEDS15427. Epub 2016 Aug 26.
- Background: PubMed 38489823Yue JK, Lee YM, Sun X, van Essen TA, Elguindy MM, Belton PJ, Pisica D, Mikolic A, Deng H, Kanter JH, McCrea MA, Bodien YG, Satris GG, Wong JC, Ambati VS, Grandhi R, Puccio AM, Mukherjee P, Valadka AB, Tarapore PE, Huang MC, DiGiorgio AM, Markowitz AJ, Yuh EL, Okonkwo DO, Steyerberg EW, Lingsma HF, Menon DK, Maas AIR, Jain S, Manley GT; The TRACK-TBI Investigators. Performance of the IMPACT and CRASH prognostic models for traumatic brain injury in a contemporary multicenter cohort: a TRACK-TBI study. J Neurosurg. 2024 Mar 15;141(2):417-429. doi: 10.3171/2023.11.JNS231425. Print 2024 Aug 1.
- Background: PubMed 16331165Maas AI, Hukkelhoven CW, Marshall LF, Steyerberg EW. Prediction of outcome in traumatic brain injury with computed tomographic characteristics: a comparison between the computed tomographic classification and combinations of computed tomographic predictors. Neurosurgery. 2005 Dec;57(6):1173-82; discussion 1173-82. doi: 10.1227/01.neu.0000186013.63046.6b.
- Background: PubMed 39138720Martin FP, Goronflot T, Moyer JD, Huet O, Asehnoune K, Cinotti R, Gourraud PA, Roquilly A. Predictive Models of Long-Term Outcome in Patients with Moderate to Severe Traumatic Brain Injury are Biased Toward Mortality Prediction. Neurocrit Care. 2025 Apr;42(2):573-586. doi: 10.1007/s12028-024-02082-3. Epub 2024 Aug 13.
- Background: PubMed 31055004Sta Maria NS, Sargolzaei S, Prins ML, Dennis EL, Asarnow RF, Hovda DA, Harris NG, Giza CC. Bridging the gap: Mechanisms of plasticity and repair after pediatric TBI. Exp Neurol. 2019 Aug;318:78-91. doi: 10.1016/j.expneurol.2019.04.016. Epub 2019 May 2.
- Background: PubMed 36694026Speer EM, Lee LK, Bourgeois FT, Gitterman D, Hay WW Jr, Davis JM, Javier JR. The state and future of pediatric research-an introductory overview : The state and future of pediatric research series. Pediatr Res. 2023 Jan 24:1-5. doi: 10.1038/s41390-022-02439-4. Online ahead of print.
- Background: PubMed 27018009Dewan MC, Mummareddy N, Wellons JC 3rd, Bonfield CM. Epidemiology of Global Pediatric Traumatic Brain Injury: Qualitative Review. World Neurosurg. 2016 Jul;91:497-509.e1. doi: 10.1016/j.wneu.2016.03.045. Epub 2016 Mar 25.
- Individual participant dataSharing planned: No. As per the data share agreement with existing datasets, the combined dataset will only be used for the prediction modelling. However, the individual dataset controllers maybe willing to consider valid scientific requests as per their arrangements
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (TBI), run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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 Score. (time frame: 6 months). 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 NCT07538440, which also lists 9 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 17 Sep 2026.