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The Anaesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury (KETA-BID)
EU CTIS ID: 2024-515315-22-00
What this study is testing
This pilot and feasibility trial – the KETA-BID trial – aims to investigate the efficacy and safety of S-ketamine on the occurrence of SDs and the feasibility of the setup. More specifically, the KETABID trial investigates the efficacy of S-ketamine in patients in whom SDs persist despite physiological optimisation.
- Therapeutic use (Phase IV)
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
- Age ≥ 18 years
- Admitted to the Neurointensive Care Unit with a diagnosis of traumatic brain injury, aneurysmal subarachnoid hemorrhage or spontaneous intracerebral hemorrhage
- At sites with ECoG as standard of care: ECoG placed on clinical indication.
- At sites where ECoG is not standard of care: planned for neurosurgical procedure that allows for placement of an ECoG electrode.
- Expected to continue sedation and mechanical ventilation after surgery.
You likely can't join if
- Neither patient nor next of kin understand English or the national language spoken at the including site.
- Known allergy to S-ketamine (the active pharmaceutical ingredient or the excipients)
- Pregnancy (all female participants aged ≤ 50 years will have a urine or blood hCG to control for pregnancy)
- Active anti-psychotic treatment before admission
- Current abuse of ketamine
- Decision to withdraw active treatment
See the full eligibility criteria
- Age ≥ 18 years
- Admitted to the Neurointensive Care Unit with a diagnosis of traumatic brain injury, aneurysmal subarachnoid hemorrhage or spontaneous intracerebral hemorrhage
- At sites with ECoG as standard of care: ECoG placed on clinical indication.
- At sites where ECoG is not standard of care: planned for neurosurgical procedure that allows for placement of an ECoG electrode.
- Expected to continue sedation and mechanical ventilation after surgery.
- Neither patient nor next of kin understand English or the national language spoken at the including site.
- Known allergy to S-ketamine (the active pharmaceutical ingredient or the excipients)
- Pregnancy (all female participants aged ≤ 50 years will have a urine or blood hCG to control for pregnancy)
- Active anti-psychotic treatment before admission
- Current abuse of ketamine
- Decision to withdraw active treatment
- Intracerebral hemorrhage secondary to a known brain tumour at the time of inclusion.
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.