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The Anaesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury

RecruitingPhase 4Ages 18 Years - anyAllCopenhagen University Hospital, Rigshospitalet
NCT05095857 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Cortical spreading depolarisations are pathological depolarisation waves that occur frequently after severe acute brain injury and has been associated with poor outcome. S-ketamine has been shown to inhibit cortical spreading depolarisations. The aim of the present study is to examine the efficacy and safety of using S-ketamine for treatment of patients with severe acute brain injury, as well as the feasibility of the trial design.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years. * Admitted to the NICU with a diagnosis of traumatic brain injury (TBI), aneurysmal subarachnoid haemorrhage (aSAH) or spontaneous intracerebral haemorrhage (ICH). * Planned for surgery with a supratentorial craniotomy or craniectomy. * Expected to continue sedation and mechanical ventilation after surgery. Exclusion Criteria: * Neither patient or next of kin understand Danish or English. * Known allergy to S-ketamine (the active pharmaceutical ingredient or the excipients). * Wake-up call to occur immediately after surgery. * Pregnancy (all female participants aged ≤ 50 years will have a urine or blood hCG taken to control for pregnancy). * Active anti-psychotic treatment before admission. * Current abuse of ketamine. * Decision to withdraw active treatment. * ICH secondary to a known brain tumour at the time of inclusion. Since this is an emergency trial informed consent will be obtained from a trial guardian before inclusion of the participant, and informed consent will be sought from next of kin as soon as possible.
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What it tests

  • S-ketamine
  • Isotonic saline (placebo)
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Where

1 site
Rigshospitalet
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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