Antisecretory Factor In Severe Traumatic Brain Injury

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT04117672

Run by

Peter Siesjö

People needed

20

Starts

2020-03-10

Expected to finish

2027-06-30

Last updated by the study team

2026-01-21

Who can join

Age: 10 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Known egg yolk allergy.
• Unilateral or bilateral fixed and dilated pupil after initial operative intervention.

Where it is running

• Skane University Hopsital — Lund, Sweden (enrolling)

Full record on ClinicalTrials.gov

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