RecruitingPhase 4ketamine

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

NCT ID

NCT05095857

Target Enrollment

400 participants

Start Date

2023-09-15

Est. Completion

2028-09-15

About This Study

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.

Conditions Studied

Subarachnoid Hemorrhage, AneurysmalIntracerebral HemorrhageTraumatic Brain Injury

Interventions

•S-ketamine
•Isotonic saline (placebo)

Eligibility

Age:18 Years - N/A

Healthy Volunteers:No

View full 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.

Study Locations (1)

Rigshospitalet