RecruitingPhase 4

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

Denmark400 participantsStarted 2023-09-15

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence of SDs after randomisation

Timeframe: From randomisation to end of ECoG monitoring, expected to be a maximum of 14 days

Trial details

NCT IDNCT05095857

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-15

Contact for this trial

Trine H Andreasen, MD

+4535455982 trine.hjorslev.andreasen@regionh.dk

View on ClinicalTrials.gov More Subarachnoid Hemorrhage, Aneurysmal trials