Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05095857

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Rigshospitalet

Copenhagen, Denmark

Actively Recruiting

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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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