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Antisecretory Factor In Severe Traumatic Brain Injury

RecruitingPhase 2Ages 10 Years - 70 YearsAllPeter Siesjö
NCT04117672 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: Severe traumatic brain injury, Glasgow Outcome Scale (GCS) \<9 at admission to NICU. Clinical indication for insertion of intracranial pressure monitor, intracerebral oxygen pressure monitor and microdialysis catheter. Consultation with relatives or consent from guardians. Exclusion Criteria: Known egg yolk allergy. Unilateral or bilateral fixed and dilated pupil after initial operative intervention.
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What it tests

  • Salovum
  • Placebo egg yolk powder
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Where

1 site
Skane University Hopsital
Lund, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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