Using ketamine to treat severe acute brain injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the efficacy and safety of S-ketamine in patients suffering from severe acute brain injuries, such as traumatic brain injury and hemorrhages. It focuses on the role of cortical spreading depolarisations, which are linked to poor outcomes in these patients. Participants will be randomly assigned to receive either S-ketamine or a placebo while being monitored in a neuro-intensive care unit. The study aims to assess the feasibility of this treatment approach and its potential to improve neurological outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rigshospitalet
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Trine H Andreasen, MD — Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Trine H Andreasen, MD
• Email: trine.hjorslev.andreasen@regionh.dk
• Phone: +4535455982

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.