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

Study acronym: KETA-BID
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Dec 1, 2026 to Sep 15, 2028
    • Eligibility criteria expanded, about 25 words
    • Study title revised
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 1, 2022 to Sep 15, 2023
    • Study sites: 0 to 1
    v4
  3. Eligibility criteria expanded, about 4 wordsv3
  4. Start date: Dec 1, 2021 to Mar 1, 2022
    • Primary endpoint revised
    • Secondary endpoints revised (2)
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05095857
Lead Sponsor Copenhagen University Hospital, Rigshospitalet
Collaborators: Copenhagen Trial Unit, Center for Clinical Intervention Research
Conditions
(from sponsor)		 Subarachnoid Hemorrhage, Aneurysmal, Intracerebral Hemorrhage, Traumatic Brain Injury
Related terms Brain Injuries, Traumatic, Cerebral Hemorrhage, Subarachnoid Hemorrhage
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov