Antisecretory Factor In Severe Traumatic Brain Injury
NCT04117672 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-01-21
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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