Clinical Trial

Antisecretory Factor In Severe Traumatic Brain Injury

Study acronym: AFISTBI
Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2019-10-03; most recent amendment 2026-01-16.
Status change: Not Yet Recruiting → Recruiting 2020-03-10
Trial Details
NCT Number NCT04117672
Lead Sponsor Peter Siesjö
Collaborators: Skane University Hospital, Lantmannen Medical AB
Conditions Traumatic Brain Injury
Enrollment 20 participants
Start Date 2020-03-10
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-21