Traumatic Brain InjuryNCT07901712
Blood NfL and Functional Outcomes After Moderate-to-Severe TBI
An observational study of Traumatic Brain Injury, run by Rutgers, The State University of New Jersey.
Trial summary
Prospective cohort study of 150 adults with moderate-to-severe TBI. Blood NfL is measured at admission, day 1, and day 3 to examine its relationship, alone and with CT imaging, to 3-month functional outcome (GOSE). 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?
- neurofilament light chain ECLIA
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2027to 31 Dec 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Moderate-to-severe traumatic brain injury (TBI) is a major cause of death and long-term neurological disability. During acute hospitalization, clinicians must make consequential decisions and counsel patients and families about prognosis despite substantial uncertainty in individual recovery. Current prognostic assessment relies on clinical examination, injury severity, neuroimaging, and other established predictors, but these measures do not directly quantify the evolving neuroaxonal injury following TBI.
Who may be able to join
- Age 18 years or older.
- Admission to University Hospital with moderate-to-severe TBI from any injury mechanism.
- Moderate-to-severe TBI defined by GCS 3-12
- Enrollment within 24 hours of presentation to UH
- Informed consent from the participant or an authorized surrogate through the approved consent process.
Who cannot join
- Age younger than 18 years, because this study is limited to adults.
- Injury that does not meet the study's definition of moderate-to-severe TBI.
- Presentation outside the approved enrollment window.
- Inability to obtain participant or authorized surrogate consent within the enrollment window.
About this study
Official title: Blood Neurofilament Light Chain and Functional Outcomes After Moderate-to-Severe Traumatic Brain Injury: A Prospective Cohort Study
Prospective cohort study of 150 adults with moderate-to-severe TBI. Blood NfL is measured at admission, day 1, and day 3 to examine its relationship, alone and with CT imaging, to 3-month functional outcome (GOSE).
- Conditions
- Traumatic Brain Injury
- Being tested
- neurofilament light chain ECLIA
- Keywords
- neurofilament light chain, moderate TBI, severe TBI, neuroprognostication
- Medical subject headings
- Brain Injuries, Traumatic, Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurofilament light chain ECLIADiagnostic test
University Hospital phlebotomists will collect blood during scheduled clinical blood collection at admission, day 1, and day 3, including one additional 1 mL research tube drawn at the same venipuncture, so no additional needle insertion is expected. Clinical care takes priority; collection will be deferred or omitted if the treating team considers it unsafe.
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale Extended
Measured: 3 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 May 2027 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion31 Dec 2029 (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 Rutgers, The State University of New JerseyThe 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
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Elizabeth Glass, MD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901712
- Sponsor's protocol ID
- Pro2026002229
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Neurofilament Light Chain and Functional Outcomes After Moderate-to-Severe Traumatic Brain Injury: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07901712
- Acronym / sponsor ID
- Pro2026002229
- Conditions
- Traumatic Brain Injury
- Keywords
- neurofilament light chain, moderate TBI, severe TBI, neuroprognostication
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 May 2027 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Oct 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.
Prospective cohort study of 150 adults with moderate-to-severe TBI. Blood NfL is measured at admission, day 1, and day 3 to examine its relationship, alone and with CT imaging, to 3-month functional outcome (GOSE).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Moderate-to-severe traumatic brain injury (TBI) is a major cause of death and long-term neurological disability. During acute hospitalization, clinicians must make consequential decisions and counsel patients and families about prognosis despite substantial uncertainty in individual recovery. Current prognostic assessment relies on clinical examination, injury severity, neuroimaging, and other established predictors, but these measures do not directly quantify the evolving neuroaxonal injury following TBI.
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Admission to University Hospital with moderate-to-severe TBI from any injury mechanism.
- Moderate-to-severe TBI defined by GCS 3-12
- Enrollment within 24 hours of presentation to UH
- Informed consent from the participant or an authorized surrogate through the approved consent process.
Key exclusion criteria (4 listed)
- Age younger than 18 years, because this study is limited to adults.
- Injury that does not meet the study's definition of moderate-to-severe TBI.
- Presentation outside the approved enrollment window.
- Inability to obtain participant or authorized surrogate consent within the enrollment window.
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 |
|---|---|---|
| neurofilament light chain ECLIAUniversity Hospital phlebotomists will collect blood during scheduled clinical blood collection at admission, day 1, and day 3, including one additional 1 mL research tube drawn at the same venipuncture, so no additional needle insertion is expected. Clinical care takes priority; collection will be deferred or omitted if the treating team considers it unsafe. | Diagnostic test | – |
Primary outcome
Glasgow Outcome Scale Extended
Time frame: 3 months post-injury
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 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Rutgers, The State University of New Jersey.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Scale Extended (time frame: 3 months post-injury). 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 Oct 2026.