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Antisecretory Factor In Severe Traumatic Brain Injury

Study acronym: AFISTBI
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Dec 31, 2024 to Dec 31, 2026
    • Primary endpoints: 4 to 1
    • Study completion date: Jun 30, 2025 to Jun 30, 2027
    • Secondary endpoints: 2 to 1
    v8
  2. Primary completion date: Mar 31, 2024 to Dec 31, 2024
    • Primary endpoints: 6 to 4
    • Study completion date: Sep 30, 2024 to Jun 30, 2025
    • Secondary endpoints: 4 to 2
    v7
  3. Primary completion date: Mar 31, 2023 to Mar 31, 2024
    • Study completion date: May 31, 2023 to Sep 30, 2024
    v6
  4. Primary completion date: Mar 31, 2022 to Mar 31, 2023
    • Study completion date: May 31, 2022 to May 31, 2023
    v5
  5. Primary completion date: Mar 31, 2021 to Mar 31, 2022
    • Study completion date: Mar 31, 2022 to May 31, 2022
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2020 to Mar 10, 2020
    • Site details revised
    v3
  2. Start date: Nov 1, 2019 to Feb 1, 2020
    • Primary completion date: Dec 31, 2020 to Mar 31, 2021
    • Study completion date: Dec 31, 2020 to Mar 31, 2022
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study evaluates the addition of Salovum, an egg yolk powder enriched for antisecretory factor, to standard care of participants with severe traumatic brain injury. Half of the participants will be administered Salovum while the other half will be given a placebo egg yolk powder, not enriched for antisecretory factor. Intracranial pressure (ICP), partial brain oxygen pressure (PtbO2), microdialysis of metabolites and inflammatory mediators and trauma intensity level (TIL) will be assessed in all patients.
Trial Details
NCT Number NCT04117672
Lead Sponsor Peter Siesjö
Collaborators: Skane University Hospital, Lantmannen Medical AB
Conditions
(from sponsor)		 Traumatic Brain Injury
Related terms Brain Edema, Brain Injuries, Traumatic
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov