NCT06062628 Ketamine in Severe Traumatic Brain Injury
| NCT ID | NCT06062628 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2026-06-01 with a primary completion date of 2026-12.
⚠ 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
Traumatic brain injury (TBI) accounts for approximately 2.5 million visits to emergency departments in the United States each year. After decades of research, management strategies for severe TBI (sTBI) patients are still evolving. Optimizing intracranial pressure (ICP) and cerebral perfusion pressure (CPP) are paramount in the management of these patients and placement of these monitors is the current standard-of-care. However, monitoring brain oxygenation (PbtO2) with invasive intraparenchymal monitors is currently under investigation in the management of severe TBI and placement of these monitors is gaining widespread use. This has opened the door for the use of tiered therapy to optimize ICP and PbtO2 simultaneously. Current evidence indicates that correction of ICP, CPP and PbtO2 in sTBI requires optimized analgesia and sedation. Ketamine is one of the few drugs available that has both sedative and analgesic properties and does not commonly compromise respiratory drive like opioids and sedative-hypnotics. However, traditionally, ketamine has been viewed as contraindicated in the setting of TBI due to concerns for elevation in ICP. Yet, new data has cast this long-held assumption into significant doubt. Hence the present pilot study will characterize the neurophysiological response to a single dose of ketamine in critically-ill TBI patient with ICP and PbtO2 monitoring.
Eligibility Criteria
Inclusion Criteria: * Severe traumatic brain injury * Placement of intracranial monitor for measurement of intracranial pressure and brain tissue oxygenation * Age greater than or equal to 18 years Exclusion Criteria: * Documented allergy to ketamine * Sinus tachycardia with sustained heart rate \>120 * Any episode of non-sinus tachycardia * Documented history of schizophrenia * Systolic blood pressure \> 180, diastolic blood pressure \> 120 * Documented episode(s) of ICP elevations \>25 mm Hg sustained greater than 5 minutes within 24 hours * Similar episodes as above of PbtO2 \<15 mmHg * Positive pregnancy test and/or is currently breast-feeding
Contact & Investigator
Anna Bashmakov, D.O.
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06062628 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.
What phase is the NCT06062628 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06062628 currently recruiting?
Yes, NCT06062628 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Texas Southwestern Medical Center to inquire about joining.
Where is the NCT06062628 trial being conducted?
This trial is being conducted at Dallas, United States, Dallas, United States.
Who is sponsoring the NCT06062628 clinical trial?
NCT06062628 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Anna Bashmakov, D.O. at University of Texas Southwestern Medical Center. The trial plans to enroll 10 participants.