A Phase 2 interventional study of Salovum in Head Trauma, Intensive Care Neurological Disorder and Edema Brain, sponsored by Peter Siesjö. Withdrawn. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-12-12.
Sponsored by Peter Siesjö · Phase 2, Interventional, and Treatment
Introduction/Background Brain swelling/brain edema can occur due to many pathologies of the brain, such as infections, ischemia and trauma.
The edema can be either primarily intra-cellular or extra-cellular. The mechanisms by which edema arise are not fully known but it is proposed that inside the damaged brain, fluid will pass over the blood-brain barrier of the vessels into the extra-cellular space. The accumulation of fluid will lead to an increase in distance between the cell and its closest capillary, which may lead to energy failure and intra-cellular edema. The extra volume of the fluid leads to increased intracranial pressure, which in turn leads to an increase in blood pressure, aggravating the edema. In addition to the physiological changes that occur, the edema will be increased by the immunological response to the tissue damage with release of pro-inflammatory cytokines that give rise to both extra- and intra-cellular edema.
Today, no treatment has been proven efficient against traumatic brain edema. AF - anti-secretory factor is a 41 kDa protein that exists in humans and most animals. It was discovered due to its ability to inhibit experimental diarrhea.
AF has been proven to have an effect on Mb Menière and glaucoma. In animal models, AF has been proven efficient in reducing increased intracranial pressure caused by trauma and virus infection in the brain.
Salovum®, an egg yolk powder enriched in AF, is registered in the European Union as a medical food.
Methods: 5 adult patients with severe traumatic brain injury will be included in the trial via next of kin consent.
Medical interventions are protocol based. The protocol includes first, second and third treatment levels.
Patients included in the trial, will receive two micro-dialysis (MD) catheters in addition to standard treatment. One catheter will be placed in a separate burr hole close to the ICP and LICOX catheter, the other MD catheter will be placed in vicinity of the damaged barin tissue.
Patients will receive Salovum® 6 hours after trial inclusion. Patient dosage is 1g/kg body weight/24 hours, divided into 6 doses and administered orally, via tubing every 4 hours for 5 consecutive days.
Objective: Primary end-point is to investigate if Salovum® has a beneficiary effect on ICP.
Secondary endpoints are to investigate if Salovum® has a beneficiary effect on treatment intensity levels (TIL), brain-oxygenation, microdialysis bio-chemistry and cytokine expression in plasma and microdialysate.
MD will be analysed bedside hourly for patient management, and the remaining MD samples will be frozen in -70° C for later analysis of cytokines.
An extra blood sample will be drawn twice daily, blood will be centrifuged and plasma will be frozen in -70° C for later analysis of cytokines.
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
Browse Craniocerebral Trauma studies →Peter Siesjö is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
CT scan with traumatic pathology that is more than an isolated epidural hematoma
Exclusion Criteria:
Patients will be given Salovum 1g/kg body weight/24 hours, divided into 6 dosages and given during 5 consecutive days.
Dietary Supplement: Salovum
Salovum is freeze dried egg yolk, highly enriched with anti-secretory factor. Salovum is registered as a medical food by the EU
ICP
Intracranial pressure in mm Hg
Time frame: Up to 7 days
PtO2
Brain tissue oxygenation in mm Hg
Time frame: Up to 7 days
Microdialysis biochemistry
Analysis of glucose, pyruvate and lactate from micro-dialysis fluid
Time frame: Up to 7 days
Cytokine expression
Analysis of cytokines from micro-dialysis fluid
Time frame: Up to 7 days
TIL
Treatment Intensity Level, scale 0-38
Time frame: Up to 7 days
No study locations are listed for this record.
This study is withdrawn, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Antisecretory Factor-enriched Egg Yolk Powder Supplement
Peter Siesjö