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

Part of paid clinical trials in Sacramento, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT07455136
Status
Recruiting
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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood sample collection — PROCEDURE
    Blood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.

Study Details

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).

Key Dates

Start date
Feb 9, 2026
Status verified
May 2026
Primary completion
Mar 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: Cohort 1: Participants with Suspected TBI
  • Arm: Cohort 2: Hospitalized Participants with TBI

Primary Outcome Measure

Percentage of Participants According to Traumatic Brain Injury (TBI) Diagnosis (Positive or Negative), Assessed by an Adjudication Panel Based on Structural Imaging (CT and MRI) and Clinical Summaries [ Time Frame: Up to 2 weeks post-injury ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
University Of California Davis, Neurological SurgerySacramentoCalifornia95817-
University of California San FranciscoSan FranciscoCalifornia94110-
Goodman Campbell Brain and Spine/AscensionCarmelIndiana46032-
Northwell Health - Department Of NeurosurgeryManhassetNew York11030-
Atrium Health - Carolina Medical CenterCharlotteNorth Carolina28203-
University of CincinnatiCincinnatiOhio45229-
University of Pennsylvania Medical CenterPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Brown UniversityProvidenceRhode Island29903-
Vanderbilt University Medical CenterNashvilleTennessee37203-
University of UtahSalt Lake CityUtah84132-
University of WisconsinMadisonWisconsin53792-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Sacramento, CA

By research site
University Of California Davis, Neurological Surgery· Sacramento, CAUniversity of California San Francisco· San Francisco, CAGoodman Campbell Brain and Spine/Ascension· Carmel, INNorthwell Health - Department Of Neurosurgery· Manhasset, NYAtrium Health - Carolina Medical Center· Charlotte, NCUniversity of Cincinnati· Cincinnati, OH

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