NCT07455136 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
| NCT ID | NCT07455136 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hoffmann-La Roche |
| Condition | Traumatic Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2026-02-09 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2026-02-09 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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
Contact & Investigator
Clinical Trials
STUDY DIRECTOR
Roche Diagnostics GmbH
Frequently Asked Questions
Who can join the NCT07455136 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07455136 currently recruiting?
Yes, NCT07455136 is actively recruiting participants. Contact the research team at marian.martinez@external.roche.com for enrollment information.
Where is the NCT07455136 trial being conducted?
This trial is being conducted at Sacramento, United States, San Francisco, United States, Carmel, United States, Charlotte, United States and 8 additional locations.
Who is sponsoring the NCT07455136 clinical trial?
NCT07455136 is sponsored by Hoffmann-La Roche. The principal investigator is Clinical Trials at Roche Diagnostics GmbH. The trial plans to enroll 2,000 participants.