Antisecretory Factor In Severe Traumatic Brain Injury

NCT04117672 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-21

No results posted yet for this 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Salovum

Active egg yolk powder

DIETARY_SUPPLEMENT

Placebo egg yolk powder

Normal egg yolk powder

Sponsors & Collaborators

  • Skane University Hospital

    collaborator OTHER
  • Lantmannen Medical AB

    collaborator OTHER
  • Peter Siesjö

    lead OTHER

Principal Investigators

  • Peter Siesjö, MD, PhD · Skane University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04117672 on ClinicalTrials.gov