Antisecretory Factor May Reduce ICP in Severe TBI—A Case Series

Cederberg, David; Hansson, Hans; Visse, Edward; Siesjö, Peter

doi:10.3389/fneur.2020.00095

Cited by 4 publications

(7 citation statements)

References 20 publications

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“…In the first two patients in which Salovum® was delivered repeatedly via a nasogastric tube, there was an increased gastric retention of the solution due to gastrointestinal dysmotility which often is present in mechanically ventilated, critically ill patients, especially those with intracranial hypertension receiving opioids for analgesia and sedation [13,18]. This observation is in line with the recent findings by Cederberg et al investigating the effects of AF in patients with severe TBI after nasogastric administration of Salovum® [4]. The retention was stressful to the patients, and no obvious ICP reduction was observed (cf.…”

Section: Discussionsupporting

confidence: 83%

Elevated intracranial pressure after head trauma can be suppressed by antisecretory factor—a pilot study

et al. 2020

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Background Control of intracranial pressure (ICP) is a key element in neurointensive care for directing treatment decisions in patients with severe traumatic brain injury (TBI). The anti-inflammatory protein antisecretory factor (AF) has been demonstrated to reduce experimentally induced high ICP in animal models. This report describes the first steps to investigate the uptake, safety, and influence of AF for reduction of elevated ICP in patients with TBI in a clinical setting. Method Four patients with severe TBI (Glasgow Coma Scale < 9) that required neurointensive care with ICP monitoring due to signs of refractory intracranial hypertension were investigated. One hundred milliliters of Salovum®, a commercially available egg yolk powder with high contents of AF peptides, was administrated either via nasogastric (patients 1 and 2) or rectal tube (patients 2, 3, and 4) every 8 h for 2 to 3 days as a supplement to the conventional neurointensive care. ICP was registered continuously. Plasma levels of AF were measured by enzyme-linked immunosorbent assay (ELISA) to confirm that Salovum® was absorbed appropriately into the bloodstream. Results In the first two patients, we observed that when delivered by the nasogastric route, there was an accumulation of the Salovum® solution in the stomach with difficulties to control ICP due to impaired gastric emptying. Therefore, we tested to administer Salovum® rectally. In the third and fourth patients, who both showed radiological signs of extensive brain edema, ICP could be controlled during the course of rectal administration of Salovum®. The ICP reduction was statistically significant and was accompanied by an increase in blood levels of AF. No adverse events that could be attributed to AF treatment or the rectal approach for Salovum® administration were observed. Conclusions The outcomes suggest that AF can act as a suppressor of high ICP induced by traumatic brain edema. Use of AF may offer a new therapeutic option for targeting cerebral edema in clinical practice. Keywords Traumatic brain injury. Brain edema. Intracranial hypertension. Antisecretory factor. Salovum®. AF-16 ELISA This article is part of the Topical Collection on Brain trauma

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Section: Discussionsupporting

confidence: 83%

Elevated intracranial pressure after head trauma can be suppressed by antisecretory factor—a pilot study

et al. 2020

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“…Antisecretory factor given as a food supplement, Salovum®, preliminarily appears to have an effect on the, often deleterious, secondary events following severe head trauma [ 4 , 6 ]. The common view on TBI is that the pathogenic mechanisms are heterogenous and that trials aiming to improve outcome should enroll a large number of participants [ 17 ] and use prognostic tools as the IMPACT [ 19 ].…”

Section: Discussionmentioning

confidence: 99%

“…However, the substance has been given to a large number of patients with equivalent doses, without any side effects. The dosage used in this trial is also similar to the ones used in reported cases series using Salovum in TBI [ 4 , 6 ], a pilot trial for treatment of cholera [ 1 ] and trials for pediatric diarrhea [ 24 , 25 ], the latter with a dose up to 16 g to infants 6–24 months old. The rationale behind the dosage and intervals is that previous studies have shown zero toxicity and that the protein is endogenous, which justifies administration of high doses of protein in order to ensure that enough AF-16 is available in the blood to make a clinical difference.…”

Section: Discussionmentioning

confidence: 99%

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Effect of antisecretory factor, given as a food supplement to adult patients with severe traumatic brain injury (SASAT): protocol for an exploratory randomized double blind placebo-controlled trial

Cederberg

Harrington

Vlok

et al. 2022

Trials

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Background Traumatic brain injury (TBI) constitutes a global epidemic. Overall outcome is poor, with mortality ranging from 10 to 70% and significant long-term morbidity. Several experimental reports have claimed effect on traumatic edema, but no clinical trials have shown effect on edema or outcome. Antisecretory factor, an endogenous protein, is commercially available as Salovum®, which is classified as a medical food by the European Union and has shown effect in experimental trauma models and feasibility with signs of effect in 2 pilot case series. The aim of this study is to assess the effect of antisecretory factor in adult patients with severe traumatic brain injury as measured by 30-day mortality, treatment intensity level (TIL), and intracranial pressure (ICP). Methods/design This is a single-center, double-blind, randomized, placebo-controlled clinical phase 2 trial, investigating the clinical superiority of Salovum® given as a food supplement to adults with severe TBI (GCS < 9), presenting to the trauma unit at Tygerberg University Hospital, Cape Town, South Africa, that are planned for invasive ICP monitoring and neurointensive care, will be screened for eligibility, and assigned to either treatment group (n = 50) or placebo group (n = 50). In both groups, the primary outcome will be 30-day mortality, recorded via hospital charts, follow-up phone calls, and the population registry. Secondary outcomes will be treatment intensity level (TIL), scored from hospital charts, and ICP registered from hospital data monitoring. Trial registration ClinicalTrials.gov NCT03339505. Registered on September 17, 2017. Protocol version 3.0 from November 13, 2020

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“…Salovum and SPC-flakes are classified as medical food by the European Union and can be bought without a prescription in pharmacies in Sweden. Salovum has been used in clinical trials for a variety of conditions, including diarrheal diseases [ 11 – 13 ], inflammatory bowel disease [ 9 , 14 , 15 ], Ménière’s disease [ 16 – 20 ] and traumatic brain injury [ 21 , 22 ]. No adverse effects have been reported, even in high doses [ 13 , 15 , 23 ].…”

Section: Introductionmentioning

confidence: 99%

Antisecretory factor is safe to use as add-on treatment in newly diagnosed glioblastoma

et al. 2023

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Purpose Glioblastoma (GBM) is the most common primary malignant brain tumor in adults. Despite the best available treatment, prognosis remains poor. Current standard therapy consists of surgical removal of the tumor followed by radiotherapy and chemotherapy with the alkylating agent temozolomide (TMZ). Experimental studies suggest that antisecretory factor (AF), an endogenous protein with proposed antisecretory and anti-inflammatory properties, may potentiate the effect of TMZ and alleviate cerebral edema. Salovum is an egg yolk powder enriched for AF and is classified as a medical food in the European Union. In this pilot study, we evaluate the safety and feasibility of add-on Salovum in GBM patients. Methods Eight patients with newly diagnosed, histologically confirmed GBM were prescribed Salovum during concomitant radiochemotherapy. Safety was determined by the number of treatment-related adverse events. Feasibility was determined by the number of patients who completed the full prescribed Salovum treatment. Results No serious treatment-related adverse events were observed. Out of 8 included patients, 2 did not complete the full treatment. Only one of the dropouts was due to issues directly related to Salovum, which were nausea and loss of appetite. Median survival was 23 months. Conclusions We conclude that Salovum is safe to use as an add-on treatment for GBM. In terms of feasibility, adherence to the treatment regimen requires a determined and independent patient as the large doses prescribed may cause nausea and loss of appetite. Trial registration ClinicalTrials.gov NCT04116138. Registered on 04/10/2019.

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Antisecretory Factor May Reduce ICP in Severe TBI—A Case Series

Cited by 4 publications

References 20 publications

Elevated intracranial pressure after head trauma can be suppressed by antisecretory factor—a pilot study

Elevated intracranial pressure after head trauma can be suppressed by antisecretory factor—a pilot study

Effect of antisecretory factor, given as a food supplement to adult patients with severe traumatic brain injury (SASAT): protocol for an exploratory randomized double blind placebo-controlled trial

Antisecretory factor is safe to use as add-on treatment in newly diagnosed glioblastoma

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