TRACK-TBI Precision Medicine Part 3 - Option II

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jan 17, 2025

Keywords

ClinConnect Summary

The TRACK-TBI Precision Medicine Part 3 - Option II trial is studying whether an experimental drug can help improve recovery for adults who have suffered a traumatic brain injury (TBI). This drug is already approved by the FDA for other uses, but it is being tested in this study specifically for TBI, which is a new application. The main goal is to see how well patients recover after taking this treatment compared to those who receive a placebo, which is a harmless substance that looks like the drug but has no active ingredients.

To be eligible for this study, participants need to be adults aged 18 to 65 who have experienced a head injury and can receive treatment within 24 hours. They must have specific signs of TBI visible on a brain scan and certain blood test results. Participants should also be able to have MRI scans and must understand English or Spanish. Those interested can expect to be closely monitored throughout the study to track their recovery progress. It's important to note that this study is not yet recruiting participants, and those who have certain medical conditions or are currently pregnant or breastfeeding are not eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults (18-65 years of age, inclusive)
• • 2. Presents to a participating enrollment site and is able to receive treatment within 24 hours of head injury warranting clinical evaluation with a non- contrast cranial CT based on American College of Emergency Physicians (ACEP) Centers for Disease Control and Prevention (CDC) clinical policy for TBI imaging.
• • 3. Closest, prior to randomization GCS score of 3 to 8
• 4. Evidence of TBI on cranial CT, confirmed by:
• • Evidence of contusion and/or
• • Evidence of traumatic axonal microvascular injury (TAMVI)
• • 5. Initial GFAP blood level \>1000 pg/mL ≤ 15000 pg/mL determined using a for Research Use Only (RUO) assay(s) or an Investigation Use Only (IUO) assay(s)
• • 6. Participants able to undergo Magnetic Resonance Imaging (MRI) scans, no contraindications
• • 7. Legally Authorized Representative (LAR) willing and able to provide informed consent
• • 8. Participant/LAR able to read, speak, and understand English or Spanish (participating site dependent, where available), including the Informed Consent Form (ICF)
• Exclusion Criteria:
• • 1. Isolated epidural hematoma
• • 2. Bilaterally fixed dilated pupils in the absence of paralytic medications, or evidence of herniation on cranial CT
• • 3. Pre-existing conditions including disabling developmental, neurologic, psychiatric, medical disorder that continues to produce functional disability up to the time of injury; or imminent death based on clinical judgement
• • 4. Order for comfort care placed prior to enrollment
• • 5. Current enrollment in another interventional study
• • 6. Currently pregnant or currently breastfeeding or planning on becoming pregnant in the next 6M
• • 7. Current incarceration or in custody
• • 8. On psychiatric hold (e.g. Codes 5150, 5250)
• • 9. Ongoing pre-injury therapy with the Investigational Product (IP), currently receiving immunosuppressive therapy or any contraindicated medications (see CsA Drug contraindications/caution table in Manual of Procedures)
• • 10. Current or medical history of any allergic reactions and/or anaphylactic reactions towards CsA and cremophor (also known as kolliphor®)
• • 11. Severe polytrauma or previous conditions that would preclude conducting any study activities
• • 12. Any spinal cord injury of grade A to D on the American Spinal Injury Association (ASIA) Impairment Scale
• • 13. Primary diagnosis at the enrolling facility of ischemic or hemorrhagic stroke
• • 14. Body Mass Index (BMI) \>35
• • 15. Hemodynamic instability, per participating site physician investigator clinical judgement
• 16. Current or medical history of renal dysfunction, significant renal failure, or high-risk for renal failure, defined as:
• • Creatinine Clearance (CrCl) or estimated Glomerular Filtration Rate (eGFR) (\<60 mL/minute/1.73 m2)
• • Major rhabdomyolysis with creatine kinase \> 5,000 IU/L
• • 17. Current or medical history of hepatic disease or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \>3 times the upper limit of normal lab value at the screening/baseline visit
• • 18. Current or medical history of serious chronic viral or fungal infection
• • 19. Current or medical history of active mycobacterial infection or anti- tuberculous treatment
• • 20. Medical history of human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibody
• • 21. Any significant disease or disorder (including abnormal laboratory tests) which, in the opinion of the participating site investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study
• • 22. Low likelihood of follow up or study compliance, or any other reason, in the opinion of the participating site investigator, the participants should not participate in the study