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Not yet recruitingNCT07901712Updated Oct 28, 2026

Blood NfL and Functional Outcomes After Moderate-to-Severe TBI

An observational study in Traumatic Brain Injury, sponsored by Rutgers, The State University of New Jersey. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Rutgers, The State University of New Jersey · Observational

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
175
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Traumatic Brain Injury

Keywords

  • neurofilament light chain
  • moderate TBI
  • severe TBI
  • neuroprognostication
03

In context

Brain Injuries, Traumatic

1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.

This study's planned enrollment of 175 is above the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.

Browse Brain Injuries, Traumatic studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 506 studies on the registry; 131 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • from the participant or an authorized surrogate through the approved consent process.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
175 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testneurofilament light chain ECLIA

    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.

06

What researchers measure

Primary outcomes

  1. Glasgow Outcome Scale Extended

    Time frame: 3 months post-injury

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07901712
Responsible party
Nina Elizabeth Glass, MD (Associate Professor of Surgery, Rutgers, The State University of New Jersey) — Principal investigator
First posted
Oct 28, 2026
Start date
May 1, 2027 (estimated)
Primary completion
Apr 30, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Oct 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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