RECRUITINGPhase 2INTERVENTIONAL
Antisecretory Factor In Severe Traumatic Brain Injury
Evaluation of Antisecretory Factor in Treatment of Severe Traumatic Brain Injury With Multimodal Monitoring
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
Known egg yolk allergy.
Unilateral or bilateral fixed and dilated pupil after initial operative intervention.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DIETARY_SUPPLEMENT
Salovum
Active egg yolk powder
DIETARY_SUPPLEMENT
Placebo egg yolk powder
Normal egg yolk powder
Locations (1)
Skane University Hopsital
Lund, Sweden