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A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury

RecruitingObservational study

A Multicenter Prospective Study to Develop a Blood-based Biomarker Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adult Subjects (CLIN12.1) and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury (CLIN12.2)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Presenting to the Emergency Department with a biomechanically plausible mechanism of non-penetrating traumatic brain injury (TBI; direct impact: blow to the head, head against object, object against head; acceleration/deceleration)
* Acute brain CT completed for standard of care

Further Inclusion Criteria (specific for CLIN12.2):

* Admitted to the hospital with radiographic evidence of acute TBI
* Admitted to the intensive care unit at risk for decline related to TBI

Exclusion Criteria:

* Prior neurosurgical intervention within the last 6 months
* Major debilitating neurological disease (such as, but not limited to: stroke, CVA, mild cognitive impairment, Alzheimer's disease, Amyotrophic lateral sclerosis, Parkinson's disease, Huntington's disease, Frontotemporal dementia, tumor, epilepsy, unmanaged seizure disorder), impairing baseline awareness, cognition, or validity of outcomes assessments
* Major debilitating baseline mental health disorders (such as but not limited to schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessments
* Significant pre-existing conditions that would interfere with follow-up and outcome assessment (such as, but not limited to: chronic kidney disease, chronic cardiovascular comorbidities, alcohol or substance use disorder)
* History of melanoma
* Primary diagnosis of ischemic or hemorrhagic stroke
* Any spinal Cord Injury (American Spinal Injury Association \[ASIA\] score of A-D)
* Received chemotherapy or radiation currently or within the last year
* Patients on psychiatric hold (e.g., 5150, 5250)
* Current incarceration or in custody
* Known inability to undergo an MRI
* Currently receiving any interventional treatments as a part of an investigational study/trial (drug, device, behavioral, treatment) at the time of enrollment and/or during the course of this study
* Low likelihood of follow-up (e.g. participant or family indicating low interest, residence in another state or country, homelessness or lack of reliable contacts)
* Any condition that, in the opinion of the investigator, could interfere in the proper execution of the study procedures and/or in their future permanence in the study

About the study

The study is intended to cover two purposes: first, to develop a blood-based biomarker test for aiding the diagnosis of traumatic brain injury (TBI) in adult participants and for prognosis of outcome of TBI (CLIN12.1); and second, for monitoring the development of secondary events in adult participants diagnosed with TBI (CLIN12.2).

What is being tested

Sponsor: Hoffmann-La Roche · Participants: 2,000 · Started: Feb 9, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07455136

Locations in the U.S.

CaliforniaUniversity Of California Davis, Neurological Surgery, Sacramento
University of California San Francisco, San Francisco
IndianaGoodman Campbell Brain and Spine/Ascension, Carmel (Not yet recruiting)
New YorkNorthwell Health - Department Of Neurosurgery, Manhasset (Not yet recruiting)
North CarolinaAtrium Health - Carolina Medical Center, Charlotte
OhioUniversity of Cincinnati, Cincinnati
PennsylvaniaUniversity of Pennsylvania Medical Center, Philadelphia
University of Pittsburgh Medical Center, Pittsburgh
Rhode IslandBrown University, Providence (Not yet recruiting)
TennesseeVanderbilt University Medical Center, Nashville (Not yet recruiting)
TexasBaylor College of Medicine, Houston (Not yet recruiting)
UtahUniversity of Utah, Salt Lake City (Not yet recruiting)
WisconsinMedical College of Wisconsin, Milwaukee (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.