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NCT06062628 · ClinicalTrials.gov registry record · Early Phase 1
Ketamine in Severe Traumatic Brain Injury
A Early Phase 1 study of Traumatic Brain Injury and Traumatic Encephalopathy, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT06062628 is a Early Phase 1 study of Traumatic Brain Injury and Traumatic Encephalopathy that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 10 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT06062628, a Early Phase 1 study of Traumatic Brain Injury and Traumatic Encephalopathy, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Ketamine Hydrochloride
Study Locations (2)
Texas
- Parkland Memorial Hospital - Dallas
- Parkland Memorial Hospital - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2027-06 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06062628
The ClinicalTrials.gov registry entry for NCT06062628 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (96% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which Ketamine Hydrochloride is the first listed.
NCT06062628 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06062628 about?
NCT06062628 is a clinical study titled "Ketamine in Severe Traumatic Brain Injury". 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 pressu...
What is the current status of trial NCT06062628?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2026-06-01. Estimated completion is 2027-06.
What conditions does trial NCT06062628 study?
This clinical trial studies the following conditions: Traumatic Brain Injury, Traumatic Encephalopathy.
What interventions are being tested in trial NCT06062628?
The interventions under investigation include: Ketamine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT06062628?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06062628 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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