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Traumatic Brain InjuryNCT04602806

Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Precision Medicine Phase 2 Option 1

An observational study of Traumatic Brain Injury, run by University of California, San Francisco at 5 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This study is being conducted to validate early and ultra-early blood-based and novel imaging biomarkers of Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and neuroinflammation that may serve as predictive and pharmacodynamic biomarkers in a new cohort of moderate-severe TRACK-TBI subjects. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Traumatic Brain Injury
How many people
50 participants
Where
5 sitesUnited States
Study dates
1 Jun 2021to Apr 2030
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This is a population-based TBI study. All patients presenting with traumatic brain injury and receive a head CT scan as part of standard care within 6 hours of injury are initially eligible.

Who may be able to join

  • Age 18 - 65y inclusive
  • History or evidence of TBI, according to DoD-VA criteria
  • Glasgow Coma Scale (GCS) 3 - 15 after resuscitation in the ED
  • Head CT with evidence of trauma-related abnormality (except for isolated epidural hematoma (EDH))
  • Ability to undergo MRI within 48 hours of injury
  • Ability to obtain informed consent from participant or Legally Authorized Representative (LAR) within 6 hours of injury
  • Fluency in English or Spanish

Who cannot join

  • Unstable respiratory or hemodynamic status
  • Evidence of penetrating brain injury
  • Isolated EDH as only trauma-related CT abnormality
  • Systemic traumatic injury that would preclude participation in study, which is expected to result in long-term disability not related to TBI
  • Evidence of serious infectious complications (sepsis, bacteremia, multilobar pneumonia)
  • Acute ischemic heart disease (myocardial infarction or unstable angina)
Show all 16Show fewer
  • History of syncope or hypotension
  • Systolic blood pressure (SBP) < 90 mm Hg, Diastolic blood pressure (DBP)< 40 mm Hg for longer than 5 minutes
  • History or evidence of active malignancy
  • History of pre-existing neurologic disorder, such as dementia, mild cognitive impairment, uncontrolled epilepsy, multiple sclerosis, strokes, brain tumors, prior severe TBI, or other disorder that may confound interpretation of MRI or neuropsychological results
  • History of pre-existing disabling mental illness, such as major depression or schizophrenia
  • History or evidence of chronic heart failure or chronic renal failure
  • Low likelihood of follow-up (e.g., participant or family indicating low interest, residence in another state or country, unhoused or lack of reliable contacts)
  • Women who are pregnant or breast-feeding
  • Prisoners or patients in custody
  • Patients on psychiatric hold (e.g. 5150, 5250)

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

5 sites in 1 country

United States5 sites

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Pennsylvania/Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of California, San Francisco

    San Francisco, California, 94110

Other trials in United States

About this study

Official title: TRACK-TBI Precision Medicine Phase 2-Option I

This study is being conducted to validate early and ultra-early blood-based and novel imaging biomarkers of Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and neuroinflammation that may serve as predictive and pharmacodynamic biomarkers in a new cohort of moderate-severe TRACK-TBI subjects. The study team will enroll a cohort of moderate to severe TBI subjects (N=50), stratified according to VA/DoD criteria for these injury severities through the existing TRACK-TBI network sites to obtain novel advanced neuroimaging and more frequent biomarker sampling. Subjects will be assessed over 3 months.

Read the detailed description

In 2009, the multicenter Transforming Research and Clinical Knowledge in Traumatic Brain Injury Consortium was implemented to characterize the clinical, magnetic resonance imaging (MRI), and blood-based biomarker features of TBI to inform design of next-generation precision medicine clinical trials in TBI. Over the past 10+ years, TRACK-TBI has been supported by National Institute of Neurological Disorders and Stroke (NINDS), Department of Defense (DoD), Department of Energy (DoE), the National Football League, and other philanthropic and industry partners. TRACK-TBI has enrolled >3000 control and TBI subjects across the injury spectrum at 18 US Level 1 Trauma Centers. This effort has established the world's largest collection of TBI imaging studies and bio-specimens. The study results are already being adopted into clinical research and bedside practice. The TRACK-TBI Consortium is now primed to deliver on critical military and public health knowledge gaps and needs: objective classification of TBI based on what is termed as "mechanistic" endophenotypes, e.g., diffuse axonal injury (DAI), microvascular injury (MVI), and neuroinflammation. An endophenotype is an internal phenotype discoverable by biochemical, physiological, radiological, pathological, or other techniques, which is intermediate between a complex phenotype and the presumptive genetic or environmental contribution to a disease. Endophenotypes are quantitative, continuous variables, unlike a phenotype which is usually a binary, categorical variable. These mechanistic endophenotypes, defined by imaging and blood-based biomarkers, will direct targeted treatments based on mechanism, providing the tools needed for successful execution of precision medicine clinical trials. To achieve the goal of precision medicine in TBI, it is necessary to identify subgroups of TBI patients that will respond to a targeted therapy. Investigators will assess putative blood-based and neuroimaging biomarkers for DAI, MVI, and neuroinflammation. Fluid biomarkers complement imaging markers and may provide important tools for precision medicine clinical trials. Investigators will collect acute data (early and ultra-early i.e., hours-days following injury), to validate the utility of these biomarkers in defining TBI mechanistic endophenotypes for use in clinical trials.

Specific Aim for TRACK-TBI Precision Medicine Phase 2-Option 1: To validate early and ultra-early blood based and novel imaging biomarkers of DAI, MVI, and neuroinflammation that may serve as predictive and pharmacodynamic biomarkers in a cohort of moderate-severe subjects.

Keywords
Traumatic Brain Injury, Biomarkers, Neuroimaging, Psychological Health, Concussion
Medical subject headings
Brain Injuries, Traumatic, Psychological Well-Being, Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04602806
Study groupRoleWhat they receive
Moderate to Severe TBI SubjectsAdult patients (age 18-65y inclusive) presenting to the Emergency Department (ED) with a history of acute TBI as per American Congress of Rehabilitation Medicine (ACRM) Criteria (i.e., patient has sustained a traumatically-induced physiological disruption of brain function).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Specimen for Analysis of Biomarkers

    Using advanced blood-based assay platforms, levels of blood biomarkers neurofilament light chain (NfL), Tau, Interleukin 6 (IL6), Interleukin (IL10), and Tumor Necrosis Factor (TNF) will be measured to validate their utility as early predictive and pharmacodynamic biomarkers for Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and Neuroinflammation. In addition, Ubiquitin C-terminal Hydrolase L1 (UCH-L1)/Glial fibrillary acidic protein (GFAP) markers will also be assayed for comparison. All biomarkers will be measured in picograms/milliliter (pg/mL).

    Measured: < 6 hours from the time of TBI

  2. Blood Specimen for Analysis of Biomarkers

    Using advanced blood-based assay platforms, levels of blood biomarkers neurofilament light chain (NfL), Tau, Interleukin 6 (IL6), Interleukin (IL10), and Tumor Necrosis Factor (TNF) will be measured to validate their utility as early predictive and pharmacodynamic biomarkers for Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and Neuroinflammation. In addition, Ubiquitin C-terminal Hydrolase L1 (UCH-L1)/Glial fibrillary acidic protein (GFAP) markers will also be assayed for comparison. All biomarkers will be measured in picograms/milliliter (pg/mL).

    Measured: 12 hours from the time of TBI

  3. Blood Specimen for Analysis of Biomarkers

    Using advanced blood-based assay platforms, levels of blood biomarkers neurofilament light chain (NfL), Tau, Interleukin 6 (IL6), Interleukin (IL10), and Tumor Necrosis Factor (TNF) will be measured to validate their utility as early predictive and pharmacodynamic biomarkers for Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and Neuroinflammation. In addition, Ubiquitin C-terminal Hydrolase L1 (UCH-L1)/Glial fibrillary acidic protein (GFAP) markers will also be assayed for comparison. All biomarkers will be measured in picograms/milliliter (pg/mL).

    Measured: 24 hours from the time of TBI

  4. Blood Specimen for Analysis of Biomarkers

    Using advanced blood-based assay platforms, levels of blood biomarkers neurofilament light chain (NfL), Tau, Interleukin 6 (IL6), Interleukin (IL10), and Tumor Necrosis Factor (TNF) will be measured to validate their utility as early predictive and pharmacodynamic biomarkers for Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and Neuroinflammation. In addition, Ubiquitin C-terminal Hydrolase L1 (UCH-L1)/Glial fibrillary acidic protein (GFAP) markers will also be assayed for comparison. All biomarkers will be measured in picograms/milliliter (pg/mL).

    Measured: Day 2 from the time of TBI

  5. Blood Specimen for Analysis of Biomarkers

    Using advanced blood-based assay platforms, levels of blood biomarkers neurofilament light chain (NfL), Tau, Interleukin 6 (IL6), Interleukin (IL10), and Tumor Necrosis Factor (TNF) will be measured to validate their utility as early predictive and pharmacodynamic biomarkers for Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and Neuroinflammation. In addition, Ubiquitin C-terminal Hydrolase L1 (UCH-L1)/Glial fibrillary acidic protein (GFAP) markers will also be assayed for comparison. All biomarkers will be measured in picograms/milliliter (pg/mL).

    Measured: Day 3 from the time of TBI

  6. Blood Specimen for Analysis of Biomarkers

    Using advanced blood-based assay platforms, levels of blood biomarkers neurofilament light chain (NfL), Tau, Interleukin 6 (IL6), Interleukin (IL10), and Tumor Necrosis Factor (TNF) will be measured to validate their utility as early predictive and pharmacodynamic biomarkers for Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and Neuroinflammation. In addition, Ubiquitin C-terminal Hydrolase L1 (UCH-L1)/Glial fibrillary acidic protein (GFAP) markers will also be assayed for comparison. All biomarkers will be measured in picograms/milliliter (pg/mL).

    Measured: Day 5 from the time of TBI

  7. Blood Specimen for Analysis of Biomarkers

    Using advanced blood-based assay platforms, levels of blood biomarkers neurofilament light chain (NfL), Tau, Interleukin 6 (IL6), Interleukin (IL10), and Tumor Necrosis Factor (TNF) will be measured to validate their utility as early predictive and pharmacodynamic biomarkers for Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and Neuroinflammation. In addition, Ubiquitin C-terminal Hydrolase L1 (UCH-L1)/Glial fibrillary acidic protein (GFAP) markers will also be assayed for comparison. All biomarkers will be measured in picograms/milliliter (pg/mL).

    Measured: Week 4 from the time of TBI

  8. Blood Specimen for Analysis of Biomarkers

    Using advanced blood-based assay platforms, levels of blood biomarkers neurofilament light chain (NfL), Tau, Interleukin 6 (IL6), Interleukin (IL10), and Tumor Necrosis Factor (TNF) will be measured to validate their utility as early predictive and pharmacodynamic biomarkers for Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and Neuroinflammation. In addition, Ubiquitin C-terminal Hydrolase L1 (UCH-L1)/Glial fibrillary acidic protein (GFAP) markers will also be assayed for comparison. All biomarkers will be measured in picograms/milliliter (pg/mL).

    Measured: Week 6 from the time of TBI

  9. Blood Specimen for Analysis of Biomarkers

    Using advanced blood-based assay platforms, levels of blood biomarkers neurofilament light chain (NfL), Tau, Interleukin 6 (IL6), Interleukin (IL10), and Tumor Necrosis Factor (TNF) will be measured to validate their utility as early predictive and pharmacodynamic biomarkers for Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and Neuroinflammation. In addition, Ubiquitin C-terminal Hydrolase L1 (UCH-L1)/Glial fibrillary acidic protein (GFAP) markers will also be assayed for comparison. All biomarkers will be measured in picograms/milliliter (pg/mL).

    Measured: 3 Months from the time of TBI

  10. 3 Tesla Brain Structural and Functional Magnetic Resonance Imaging (MRI)

    This study aims to validate early and ultra-early novel imaging biomarkers in the acute phase after injury. In addition to volumetrics, Diffuse Tensor Imaging (DTI) and Resting State Functional Magnetic Resonance Imaging (rs-fMRI), the MRI protocol will incorporate novel imaging measures of axonal density using neurite density index (NDI) from Neurite Orientation Dispersion And Density Imaging (NODDI) analysis of multi-shell diffusion MRI, cerebral blood flow using Arterial Spin Labeled (ASL) perfusion, and neuroinflammation using free water content isotropic diffusion fraction (FISO) from NODDI analysis of multi-shell diffusion MRI.

    Measured: Within 24-48 hours from the time of TBI

  11. 3 Tesla Brain Structural and Functional Magnetic Resonance Imaging (MRI)

    This study aims to validate early and ultra-early novel imaging biomarkers in the acute phase after injury. In addition to volumetrics, Diffuse Tensor Imaging (DTI) and Resting State Functional Magnetic Resonance Imaging (rs-fMRI), the MRI protocol will incorporate novel imaging measures of axonal density using neurite density index (NDI) from Neurite Orientation Dispersion And Density Imaging (NODDI) analysis of multi-shell diffusion MRI, cerebral blood flow using Arterial Spin Labeled (ASL) perfusion, and neuroinflammation using free water content isotropic diffusion fraction (FISO) from NODDI analysis of multi-shell diffusion MRI.

    Measured: 2 Weeks from the time of TBI

  12. 3 Tesla Brain Structural and Functional Magnetic Resonance Imaging (MRI)

    This study aims to validate early and ultra-early novel imaging biomarkers in the acute phase after injury. In addition to volumetrics, Diffuse Tensor Imaging (DTI) and Resting State Functional Magnetic Resonance Imaging (rs-fMRI), the MRI protocol will incorporate novel imaging measures of axonal density using neurite density index (NDI) from Neurite Orientation Dispersion And Density Imaging (NODDI) analysis of multi-shell diffusion MRI, cerebral blood flow using Arterial Spin Labeled (ASL) perfusion, and neuroinflammation using free water content isotropic diffusion fraction (FISO) from NODDI analysis of multi-shell diffusion MRI.

    Measured: 3 Months from the time of TBI

Secondary outcomes (3)

  1. Glasgow Outcome Scale Extended (GOSE)

    The GOSE provides an overall measure of functional status based on information on cognition, independence, employability, and social/community participation collected via structured interview. Individuals are described by one of the eight outcome categories: Dead (1); Vegetative State (2); Lower Severe Disability (3); Upper Severe Disability (4); Lower Moderate Disability (5); Upper Moderate Disability (6); Lower Good Recovery (7) and Upper Good Recovery (8). Good Recovery is defined as a score of 7-8, Moderate Disability is defined by a score of 5-6 and Severe Disability is defined by a score of 3-4.

    Measured: 2 Weeks from the time of TBI

  2. Glasgow Outcome Scale Extended (GOSE)

    The GOSE provides an overall measure of functional status based on information on cognition, independence, employability, and social/community participation collected via structured interview. Individuals are described by one of the eight outcome categories: Dead (1); Vegetative State (2); Lower Severe Disability (3); Upper Severe Disability (4); Lower Moderate Disability (5); Upper Moderate Disability (6); Lower Good Recovery (7) and Upper Good Recovery (8). Good Recovery is defined as a score of 7-8, Moderate Disability is defined by a score of 5-6 and Severe Disability is defined by a score of 3-4.

    Measured: 6 Weeks from the time of TBI

  3. Glasgow Outcome Scale Extended (GOSE)

    The GOSE provides an overall measure of functional status based on information on cognition, independence, employability, and social/community participation collected via structured interview. Individuals are described by one of the eight outcome categories: Dead (1); Vegetative State (2); Lower Severe Disability (3); Upper Severe Disability (4); Lower Moderate Disability (5); Upper Moderate Disability (6); Lower Good Recovery (7) and Upper Good Recovery (8). Good Recovery is defined as a score of 7-8, Moderate Disability is defined by a score of 5-6 and Severe Disability is defined by a score of 3-4.

    Measured: 3 Months from the time of TBI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2020
  2. Study start1 Jun 2021
  3. Primary completionApr 2030 (estimated)
  4. Study completionApr 2030 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04602806
Sponsor's protocol ID
W81XWH-18-2-0042
Status last verified
Sep 2026
First submitted
20 Oct 2020
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: * The TRACK TBI investigators have created a Data Use Agreement/Human Materials Transfer Agreement (DUA/HTMA) for TRACK-TBI Research Collaborations. This Agreement is for the use of clinical data, neuroimaging, and bio-specimens collected by the TRACK-TBI investigators. All Research Collaborators can submit a written request to the TRACK-TBI Executive Committee. * This study involves research in the area of traumatic brain injury (TBI). The Department of Defense, in collaboration with the National Institutes of Health, has developed the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System, a central repository and resource for sharing data to promote collaboration, accelerate research, and advance knowledge on the characterization, prevention, diagnosis, and treatment of TBI. The TRACK-TBI Investigators will share study data via FITBIR in accordance with FITBIR policy and procedures.

Publications

  • Maas AI, Roozenbeek B, Manley GT. Clinical trials in traumatic brain injury: past experience and current developments. Neurotherapeutics. 2010 Jan;7(1):115-26. doi: 10.1016/j.nurt.2009.10.022.

    PubMed 20129503

  • Teasdale G, Jennett B. Assessment and prognosis of coma after head injury. Acta Neurochir (Wien). 1976;34(1-4):45-55. doi: 10.1007/BF01405862.

    PubMed 961490

  • Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573.

    PubMed 9726257

  • Maas AI, Harrison-Felix CL, Menon D, Adelson PD, Balkin T, Bullock R, Engel DC, Gordon W, Orman JL, Lew HL, Robertson C, Temkin N, Valadka A, Verfaellie M, Wainwright M, Wright DW, Schwab K. Common data elements for traumatic brain injury: recommendations from the interagency working group on demographics and clinical assessment. Arch Phys Med Rehabil. 2010 Nov;91(11):1641-9. doi: 10.1016/j.apmr.2010.07.232.

    PubMed 21044707

  • Manley GT, Diaz-Arrastia R, Brophy M, Engel D, Goodman C, Gwinn K, Veenstra TD, Ling G, Ottens AK, Tortella F, Hayes RL. Common data elements for traumatic brain injury: recommendations from the biospecimens and biomarkers working group. Arch Phys Med Rehabil. 2010 Nov;91(11):1667-72. doi: 10.1016/j.apmr.2010.05.018.

    PubMed 21044710

  • Duhaime AC, Gean AD, Haacke EM, Hicks R, Wintermark M, Mukherjee P, Brody D, Latour L, Riedy G; Common Data Elements Neuroimaging Working Group Members, Pediatric Working Group Members. Common data elements in radiologic imaging of traumatic brain injury. Arch Phys Med Rehabil. 2010 Nov;91(11):1661-6. doi: 10.1016/j.apmr.2010.07.238.

    PubMed 21044709

  • Whyte J, Vasterling J, Manley GT. Common data elements for research on traumatic brain injury and psychological health: current status and future development. Arch Phys Med Rehabil. 2010 Nov;91(11):1692-6. doi: 10.1016/j.apmr.2010.06.031.

    PubMed 21044713

  • Almasy L, Blangero J. Endophenotypes as quantitative risk factors for psychiatric disease: rationale and study design. Am J Med Genet. 2001 Jan 8;105(1):42-4.

    PubMed 11424994

  • O'Neil ME, Carlson KF, Storzbach D, Brenner LA, Freeman M, Quinones AR, Motu'apuaka M, Kansagara D. Factors associated with mild traumatic brain injury in veterans and military personnel: a systematic review. J Int Neuropsychol Soc. 2014 Mar;20(3):249-61. doi: 10.1017/S1355617714000204.

    PubMed 24622505

  • Alsop DC, Detre JA, Golay X, Gunther M, Hendrikse J, Hernandez-Garcia L, Lu H, MacIntosh BJ, Parkes LM, Smits M, van Osch MJ, Wang DJ, Wong EC, Zaharchuk G. Recommended implementation of arterial spin-labeled perfusion MRI for clinical applications: A consensus of the ISMRM perfusion study group and the European consortium for ASL in dementia. Magn Reson Med. 2015 Jan;73(1):102-16. doi: 10.1002/mrm.25197. Epub 2014 Apr 8.

    PubMed 24715426

  • Dikmen S, Machamer J, Miller B, Doctor J, Temkin N. Functional status examination: a new instrument for assessing outcome in traumatic brain injury. J Neurotrauma. 2001 Feb;18(2):127-40. doi: 10.1089/08977150150502578.

    PubMed 11229707

  • McCrea M, Kelly JP, Randolph C. Standardized Assessment of Concussion (SAC): Manual for Administration, Scoring and Interpretation. 2nd ed. Waukesha, WI: CNS Inc; 2000. [Google Scholar]

  • Smith GP, Burger GK. Detection of malingering: validation of the Structured Inventory of Malingered Symptomatology (SIMS). J Am Acad Psychiatry Law. 1997;25(2):183-9.

    PubMed 9213290

  • Reitan, R.M. and D. Wolfson, The Halstead-Reitan neuropsychological test battery: Theory and clinical interpretation. Vol. 4. 1985: Reitan Neuropsychology.

  • Finkelstein E, Corso P, Miller T and Associates. The Incidence and Economic Burden of Injuries in the United States. New York (NY): Oxford University Press; 2006.

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injury, run by University of California, San Francisco at 5 sites in United States.

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 7 inclusion and 16 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: enrolling by invitation, as of the sponsor's last update on 14 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 5 sites in United States. 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?

Blood Specimen for Analysis of Biomarkers (time frame: < 6 hours from the time of TBI). The study lists 12 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 NCT04602806, which also lists 16 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 14 Sep 2026.

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