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New treatment option for Brain Injuries, Traumatic
Official title Ketamine in Acute Brain Injury Patients.
ClinicalTrials.gov ID: NCT05097261
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for brain injuries, traumatic.
Also referred to as Ketalar.
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
- 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 an adjunct to a standard sedative strategy in TBI patients.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- 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)
You likely can't join if
- Known pregnancy and/or lactation
- Imminent or actual brain death upon inclusion
- Allergy or intolerance to the study medication
- Pre-existing neurocognitive disorders, pre-existing congenital or non-congenital brain dysfunction.
- Inability to obtain informed consent
- Inclusion in an treatment assigned by chance controlled trial of which the PI indicates that co-inclusion specifically in the BIKe study is...
See the full eligibility 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
- Known pregnancy and/or lactation
- Imminent or actual brain death upon inclusion
- Allergy or intolerance to the study medication
- Pre-existing neurocognitive disorders, pre-existing congenital or non-congenital brain dysfunction.
- Inability to obtain informed consent
- Inclusion in an treatment assigned by chance controlled trial of which the PI indicates that co-inclusion specifically in the BIKe study is prohibited.
- Therapy restriction code upon inclusion.
- Porphyria
- Glaucoma
The study team makes the final eligibility decision.
Where it's taking place
- Bonheiden, Belgium
- Bruges, Belgium
- Hasselt, Belgium
- Leuven, Belgium
- Liège, Belgium
- Roeselare, Belgium
- Turnhout, Belgium
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Bonheiden, Belgium; Bruges, Belgium; Hasselt, Belgium; Leuven, Belgium; Liège, Belgium; Roeselare, Belgium and 1 more location(s). 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.