SuspendedPhase 4

Ketamine for Sedation in Severe Traumatic Brain Injury

Stopped: administrative hold at current open site and awaiting site startup at additional participating sites

United States50 participantsStarted 2024-09-23

Plain-language summary

This protocol is for an open-label randomized trial evaluating the safety of using ketamine in combination with propofol for sedation versus the standard of care analgosedation in patients admitted to the intensive care unit with severe traumatic brain injury.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults 18-65 years of age * Severe traumatic brain injury (TBI), with a Glasgow Coma Scale (GCS) ≤ 8, requiring intracranial monitoring * Placement of intracranial pressure monitor * Receiving treatment in an intensive care unit (ICU) Exclusion Criteria: * Significant cardiovascular disease with recent coronary intervention * Pregnancy * Prisoners * Known allergy to ketamine or propofol

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of ICP elevations greater than 22 mmHg for greater than 5 minutes

Timeframe: During the maximum 5-day course of study intervention, while patient is sedated and has intracranial pressure monitor in place in the ICU setting

Mean ICP

Timeframe: During the maximum 5-day course of study intervention.

Trial details

NCT IDNCT06429657

SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

View on ClinicalTrials.gov More Severe Traumatic Brain Injury trials