Actively Recruiting
The Anaesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury
Led by Rigshospitalet, Denmark · Updated on 2024-06-26
400
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
C
Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Anaesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years
- Admitted to the neurointensive care unit with 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
You will not qualify if you...
- Neither patient nor next of kin understand Danish or English
- Known allergy to S-ketamine or its components
- Wake-up call planned immediately after surgery
- Pregnancy (all females 64 50 years will have pregnancy test before inclusion)
- Active anti-psychotic treatment before admission
- Current ketamine abuse
- Decision to withdraw active treatment
- Intracerebral hemorrhage caused by a known brain tumour at the time of inclusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
Research Team
T
Trine H Andreasen, MD
CONTACT
K
Kirsten Møller, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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