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Clinical Trials in Sweden / NCT04117672
Recruiting Phase 2

Antisecretory Factor In Severe Traumatic Brain Injury

NCT04117672 · tracked via the Priya Life Science Sweden tracker
Sponsor
Peter Siesjö
Phase
Phase 2
Started
2020-03-10
Last updated
2026-01-21

Condition(s) studied

Traumatic Brain Injury

Investigational drug(s) / intervention(s)

SalovumPlacebo egg yolk powder

Salovum: Active egg yolk powder

Placebo egg yolk powder: Normal egg yolk powder

Study 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.

Eligibility

Sex
ALL
Min age
10 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • ICP mean — During intervention, 5 days
    Measured by an intracranial pressure sensor

Trial sites (1)

FacilityCityRegionStatus
Skane University Hopsital Lund Sweden Recruiting

More Peter Siesjö trials in Sweden

Antisecretory Factor Glioblastoma Phase 2 Recruiting
Effect of Salovum® on Pressure, Oxygen and Inflammation in Glioblastoma Recruiting
Impact of Salovum® and SPC® Flakes on Brain Tumor Induced Edema Recruiting

Other trials for the same condition

Internet Delivered Cognitive Rehabilitation for Mild Cognitive Impairments Enrolling by invitation
Remote Neuropsychological Assessment of Patients With Neurological Disorders and Injuries Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04117672 on ClinicalTrials.gov ↗ ← All trials in Sweden