Study of Salovum Egg Yolk Powder for Severe Traumatic Brain Injury Treatment with Brain Pressure and Oxygen Monitoring

What this Trial Is About

Researchers are evaluating the addition of Salovum, an egg yolk powder enriched with antisecretory factor AF, in the treatment of severe traumatic brain injury TBI. This phase 2 randomized study compares Salovum to a placebo egg yolk powder not enriched with AF. The study aims to understand how AF affects cerebral edema and intracranial pressure ICP, which are critical factors impacting brain function and recovery after severe injury. Participants will receive either Salovum or the placebo suspended in tap water and administered through a gastric feeding tube for five days. All participants will also receive standard care for severe TBI, including invasive monitoring of ICP, brain oxygen pressure PtbO2, and brain metabolites by cerebral microdialysis. Treatment groups are assigned by randomization with triple masking, and trauma intensity will be tracked using a trauma intensity level TIL score to adjust for co-interventions. During the study, patients will undergo continuous monitoring of ICP and inflammatory markers for five days. Researchers will also assess trauma severity and patient outcomes, including mortality and the Glasgow Outcome Scale-Extended GOSE. The study will follow participants closely to evaluate the effects of Salovum on brain injury over the treatment period and during follow-up assessments.

Antisecretory Factor In Severe Traumatic Brain Injury