Status:
RECRUITING
Ketamine in Severe Traumatic Brain Injury
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Traumatic Brain Injury
Traumatic Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 (sTB...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06062628
Start Date
December 1 2025
End Date
November 1 2026
Last Update
September 29 2025
Active Locations (2)
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1
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
2
Parkland Memorial Hospital
Dallas, Texas, United States, 75235