Using egg yolk powder to treat severe traumatic brain injury
Evaluation of Antisecretory Factor in Treatment of Severe Traumatic Brain Injury With Multimodal Monitoring
This study is testing if an egg yolk powder can help improve recovery for people with severe traumatic brain injuries when added to their regular treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 10 Years to 70 Years |
| Sex | All |
| Sponsor | Skane University Hospital Academic / other |
| Locations | 1 site (Lund) |
| Trial ID | NCT04117672 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Salovum, an egg yolk powder enriched with antisecretory factor, in addition to standard care for patients with severe traumatic brain injury. Participants will be randomly assigned to receive either Salovum or a placebo egg yolk powder, and various parameters such as intracranial pressure, brain oxygen levels, and inflammatory markers will be monitored. The goal is to assess whether Salovum can reduce cerebral edema and improve patient outcomes compared to standard treatment alone.
Who should consider this trial
Good fit: Ideal candidates are individuals with severe traumatic brain injury and a Glasgow Outcome Scale score of less than 9 upon admission.
Not a fit: Patients with known egg yolk allergies or those with fixed and dilated pupils after initial surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with severe traumatic brain injury.
How similar studies have performed: Preliminary results from similar studies have shown promise in reducing intracranial pressure and improving outcomes in traumatic brain injury.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lund
- Skane University Hopsital — Lund, Sweden (Recruiting)
Study contacts
- Principal investigator: Peter Siesjö, MD, PhD — Skane University Hospital
- Study coordinator: Peter Siesjö, MD, PhD
- Email: peter.siesjo@med.lu.se
- Phone: +4646171274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.