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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)

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University Of California Davis, Neurological Surgery
NOT_YET_RECRUITING
Sacramento
University of California San Francisco
RECRUITING
San Francisco
Indiana
Goodman Campbell Brain and Spine/Ascension
NOT_YET_RECRUITING
Carmel
North Carolina
Atrium Health - Carolina Medical Center
NOT_YET_RECRUITING
Charlotte
Ohio
University of Cincinnati
NOT_YET_RECRUITING
Cincinnati
Pennsylvania
University of Pennsylvania Medical Center
NOT_YET_RECRUITING
Philadelphia
University of Pittsburgh Medical Center
NOT_YET_RECRUITING
Pittsburgh
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Utah
University of Utah
NOT_YET_RECRUITING
Salt Lake City
Wisconsin
University of Wisconsin
NOT_YET_RECRUITING
Madison
Medical College of Wisconsin
NOT_YET_RECRUITING
Milwaukee
Contact Information
Primary
Marian Martinez
marian.martinez@contractors.roche.com
+1-815-394-9084
Time Frame
Start Date: 2026-02-09
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 2000
Treatments
Cohort 1: Participants with Suspected TBI
Cohort 2: Hospitalized Participants with TBI
Related Therapeutic Areas
Sponsors
Collaborators: Roche Diagnostics GmbH
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov

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