Actively Recruiting

Phase 2
Age: 10Years - 70Years
All Genders
NCT04117672

Antisecretory Factor In Severe Traumatic Brain Injury

Led by Peter Siesjö · Updated on 2026-01-21

20

Participants Needed

1

Research Sites

381 weeks

Total Duration

On this page

Sponsors

P

Peter Siesjö

Lead Sponsor

S

Skane University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Antisecretory Factor In Severe Traumatic Brain Injury

Who Can Participate

Age: 10Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Severe traumatic brain injury with Glasgow Coma Scale score less than 9 at admission to the Neuro Intensive Care Unit
  • Clinical need for insertion of intracranial pressure monitor, brain oxygen pressure monitor, and microdialysis catheter
  • Consent obtained from relatives or guardians
Not Eligible

You will not qualify if you...

  • Known allergy to egg yolk
  • Unilateral or bilateral fixed and dilated pupils after initial brain surgery

AI-Screening

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Trial Site Locations

Total: 1 location

1

Skane University Hopsital

Lund, Sweden, 22185

Actively Recruiting

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Research Team

P

Peter Siesjö, MD, PhD

CONTACT

D

David Cederberg, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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