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Brain Injury and Ketamine: a prospective, randomized controlled double blind clinical trial to study the effects of ketamine on therapy intensity level and intracranial pressure in acute brain injury patients.
EU CTIS ID: 2023-505319-19-00
What this study is testing
To demonstrate that associating ketamine to the sedative regime for ICP control in TBI, results in a reduction of the therapeutic intensity of ICP reducing measures, assessed by the TIL score.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Traumatic brain injury patients
- Age ≥ 18 years
- Admitted to the Intensive Care Unit
- Within 72 hours after admission to the initial hospital: ICP monitor in place (parenchymal probe, ventricular catheter, or both) and requiring sedation
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 IMP-RCT of which the PI indicates that co-inclusion specifically in the BIKe study is prohibited
See the full eligibility criteria
- Traumatic brain injury patients
- Age ≥ 18 years
- Admitted to the Intensive Care Unit
- Within 72 hours after admission to the initial hospital: ICP monitor in place (parenchymal probe, ventricular catheter, or both) and 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 IMP-RCT 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.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.