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Antisecretory factor (AF), commercially available as Salovum\u00ae, has been shown to lower intracranial pressure (ICP) in experimental models of, e.g., TBI and herpes encephalitis. The aim of this study is to assess the effect of antisecretory factors in adult patients with severe TBI on ICP and inflammatory mediators in extracellular fluid and plasma.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods\/design<\/jats:title>\n            <jats:p>This is a single-center, randomized, placebo-controlled clinical phase 2 trial, investigating the clinical superiority of Salovum\u00ae given as a food supplement during 5\u00a0days to adults with severe TBI (Glasgow Coma Scale (GCS)\u2009&lt;\u20099), admitted to the neurocritical intensive care unit (NICU) at Skane university hospital, Lund, Sweden. All patients with GCS\u2009&lt;\u20099 and clinical indication for insertion of ICP-monitor and microdialysis catheter will be screened for inclusion and assigned to either the treatment group (<jats:italic>n<\/jats:italic>\u2009=\u200910) or placebo group (<jats:italic>n<\/jats:italic>\u2009=\u200910). In both groups, the primary outcome will be ICP (mean values and change from baseline during intervention), registered from high-frequency data monitoring for 5\u00a0days. Secondary outcomes will be inflammatory mediators in plasma and intracerebral microdialysis perfusate days 1, 3, and 5 during trial treatment.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Trial registration<\/jats:title>\n            <jats:p>ClinicalTrials.gov <jats:underline>NCT04117672<\/jats:underline>. Registered on September 17, 2017. Protocol version 6 from October 24, 2023.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1186\/s13063-025-08760-7","type":"journal-article","created":{"date-parts":[[2025,2,7]],"date-time":"2025-02-07T07:02:03Z","timestamp":1738911723000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Antisecretory factor in severe traumatic brain injury (AFISTBI): protocol for an exploratory randomized placebo-controlled trial"],"prefix":"10.1186","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-9119-3357","authenticated-orcid":false,"given":"Linus","family":"R\u00e9en","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Cederberg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Niklas","family":"Marklund","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edward","family":"Visse","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Siesj\u00f6","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,2,7]]},"reference":[{"key":"8760_CR1","doi-asserted-by":"crossref","unstructured":"Injury GBDTB, Spinal Cord Injury C. 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