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

This randomised, blinded, placebo-controlled, parallel-group pilot and feasibility trial (n=400) will investigate the efficacy and safety of using esketamine for the treatment of patients with severe acute brain injury. It will specifically focus on cortical spreading depolarisations (SDs), which occur frequently after traumatic brain injury (TBI), aneurysmal subarachnoid haemorrhage (aSAH), or intracerebral haemorrhage (ICH).

The trial, conducted by Rigshospitalet, Denmark, will include participants admitted to the neurointensive care unit with TBI, aSAH, or ICH and undergoing craniotomy or craniectomy. If clustered SDs occur despite physiological optimisation, the participants will be allocated 1:1 to infusion of S-ketamine or a matching placebo.

The primary outcome measure is the occurrence of SDs after randomisation, while secondary outcome measures include the rate of adverse events, functional outcome at 6 months post-randomisation, all-cause mortality, and other measures related to neurological worsening and the feasibility of the trial design. The study started in September 2023 and is expected to be completed by December 2026.

Topic Traumatic Brain Injury
Compound Ketamine Placebo
Country Denmark
Visit trial
Status Recruiting
Results Published No
Start date 15 September 2023
End date 01 December 2026
Phase Phase IV
Design Blinded
Type Interventional
Generation First
Participants 400
Sex All
Age 17-
Therapy No

Trial Details

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.

NCT Number NCT05095857

Sponsors & Collaborators

Copenhagen University Hospital Rigshospitalet
The university hospital in Copenhagen, the Rigshospitalet, is Denmark's most prestigious (and largest) hospital. Literally translated, the name stands for 'Hospital of the Realm.' Researchers here are working on at least three psychedelic trials with psilocybin.

Data attribution

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