RecruitingPhase 2

Antisecretory Factor In Severe Traumatic Brain Injury

Sweden20 participantsStarted 2020-03-10

Plain-language summary

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.

Who can participate

Age range10 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

ICP mean

Timeframe: During intervention, 5 days

Trial details

NCT IDNCT04117672

SponsorPeter Siesjö

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Peter Siesjö, MD, PhD

+4646171274 peter.siesjo@med.lu.se

View on ClinicalTrials.gov More Traumatic Brain Injury trials