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New treatment option for Traumatic Brain Injury
Official title Ketamine in Severe Traumatic Brain Injury
ClinicalTrials.gov ID: NCT06062628
What this study is testing
What is Ketamine Hydrochloride?
Ketamine Hydrochloride is an investigational medicine, being studied as a potential treatment for traumatic brain injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.