Ketamine in Acute Brain Injury Patients.
Recruiting
Phase 4
Interventional Study
Brain Injuries, Traumatic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 100 (estimated)
- Sponsor
- Geert Meyfroidt, MD, PhD · Other
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About This Trial
Although, in the past years, an increasing use of ketamine in Traumatic Brain injury (TBI) has been reported as an adjunct to other sedatives, there is no evidence from randomized clinical trial to support this practice.
The BIKe (Brain Injury and Ketamine) study is a double-blind placebo controlled randomized multicenter clinical trial to examine the safety and feasibility of using ketamine as a…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Traumatic brain injury patients
* Age \>= 18 years
* Admitted to the ICU
* Within 72 hours after admission to the initial hospital:
* ICP monitoring in place (parenchymal probe, ventricular catheter, or both)
* Requiring sedation
Exclusion Criteria:
* Known pregnancy an…
Contacts