NCT05095857 The Anaesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury
| NCT ID | NCT05095857 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Subarachnoid Hemorrhage, Aneurysmal |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-09-15 |
| Primary Completion | 2028-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 400 participants in total. It began in 2023-09-15 with a primary completion date of 2028-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Trine H Andreasen, MD
PRINCIPAL INVESTIGATOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT05095857 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Subarachnoid Hemorrhage, Aneurysmal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05095857 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05095857 currently recruiting?
Yes, NCT05095857 is actively recruiting participants. Contact the research team at trine.hjorslev.andreasen@regionh.dk for enrollment information.
Where is the NCT05095857 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT05095857 clinical trial?
NCT05095857 is sponsored by Rigshospitalet, Denmark. The principal investigator is Trine H Andreasen, MD at Rigshospitalet, Denmark. The trial plans to enroll 400 participants.