Using ketamine to treat severe acute brain injuries
S-ketamine for Cortical Spreading Depolarisation in Patients With Severe Acute Brain Injury
This study is testing if S-ketamine can help people with severe brain injuries feel better and improve their recovery compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05095857 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been admitted to the neuro-intensive care unit with specific types of severe acute brain injuries and are planned for surgery.
Not a fit: Patients who are not undergoing surgery or have conditions such as known allergies to S-ketamine or active anti-psychotic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with severe acute brain injuries.
How similar studies have performed: While the use of ketamine in this context is novel, preliminary evidence suggests it may inhibit harmful brain activity, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Trine H Andreasen, MD — Rigshospitalet, Denmark
- Study coordinator: Trine H Andreasen, MD
- Email: trine.hjorslev.andreasen@regionh.dk
- Phone: +4535455982
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.