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Head TraumaPhase 2SATSWEDENNCT03453749

Anti-secretory Factor as a Treatment for Adults With Severe Traumatic Head Injury

A Phase 2 study testing Salovum in people with Head Trauma and Intensive Care Neurological Disorder, run by Peter Siesjö.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Salovum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Mar 2018to 10 Dec 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult of either gender between 18 and 65 years.
  • Non-penetrating, isolated severe traumatic brain injury
  • GCS >3 and GCS<9 on admission or within 48 hours after injury*
  • Admission to study hospital within 24 hours of injury*
  • No known history of allergy to egg-protein
  • Planned for intracranial pressure monitoring
Show all 9Show fewer
  • Absence of bilaterally dilated pupils
  • CT scan with traumatic pathology that is more than an isolated epidural hematoma
  • Within 24 hours of injury (for patients with GCS < 9 on admission) or Within 24 hours of deterioration (among patients deteriorating to GCS < 9 within 48 hours of injury)

Who cannot join

  • No consent
  • Systolic blood pressure below 90 mm Hg post resuscitation
  • Epidural hematoma with no other signs of intra-cranial injury
  • Penetrating injury
  • Non-fulfillment of inclusion criteria after screening and inclusion procedures.

About this study

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.

Read more

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.

Read the detailed description

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.

Being tested
Salovum
Keywords
Traumatic brain injury, Cerebral edema, Microdialysis, Inflammatory cytokines
Medical subject headings
Craniocerebral Trauma, Brain Edema, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SalovumDietary supplement

    Salovum is freeze dried egg yolk, highly enriched with anti-secretory factor. Salovum is registered as a medical food by the EU

Study groups in NCT03453749
Study groupRoleWhat they receive
SalovumOtherPatients will be given Salovum 1g/kg body weight/24 hours, divided into 6 dosages and given during 5 consecutive days.
Receives: Dietary Supplement: Salovum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ICP

    Intracranial pressure in mm Hg

    Measured: Up to 7 days

Secondary outcomes (4)

  1. PtO2

    Brain tissue oxygenation in mm Hg

    Measured: Up to 7 days

  2. Microdialysis biochemistry

    Analysis of glucose, pyruvate and lactate from micro-dialysis fluid

    Measured: Up to 7 days

  3. Cytokine expression

    Analysis of cytokines from micro-dialysis fluid

    Measured: Up to 7 days

  4. TIL

    Treatment Intensity Level, scale 0-38

    Measured: Up to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2018
  2. Study start1 Mar 2018 (estimated)
  3. Primary completion10 Dec 2018
  4. Study completion10 Dec 2018

Why it stopped: New study in planning

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
5 consecutive adult patients with severe head trauma will receive treatment
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03453749
Sponsor's protocol ID
Ethics reference: 2013/144
Acronym
SATSWEDEN
Status last verified
Dec 2018
First submitted
13 Dec 2017
Last updated
12 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Eide PK, Eidsvaag VA, Hansson HA. Antisecretory factor (AF) exerts no effects on intracranial pressure (ICP) waves and ICP in patients with idiopathic normal pressure hydrocephalus and idiopathic intracranial hypertension. J Neurol Sci. 2014 Aug 15;343(1-2):132-7. doi: 10.1016/j.jns.2014.05.054. Epub 2014 Jun 2.

    PubMed 24928077

  • Zaman S, Aamir K, Lange S, Jennische E, Silfverdal SA, Hanson LA. Antisecretory factor effectively and safely stops childhood diarrhoea: a placebo-controlled, randomised study. Acta Paediatr. 2014 Jun;103(6):659-64. doi: 10.1111/apa.12581. Epub 2014 Mar 10.

    PubMed 24484450

  • Leong SC, Narayan S, Lesser TH. Antisecretory factor-inducing therapy improves patient-reported functional levels in Meniere's disease. Ann Otol Rhinol Laryngol. 2013 Oct;122(10):619-24.

    PubMed 24294684

  • Alam NH, Ashraf H, Olesen M, Salam MA, Gyr N, Meier R. Salovum egg yolk containing antisecretory factor as an adjunct therapy in severe cholera in adult males: a pilot study. J Health Popul Nutr. 2011 Aug;29(4):297-302. doi: 10.3329/jhpn.v29i4.8443.

    PubMed 21957667

  • Ulgheri C, Paganini B, Rossi F. Antisecretory factor as a potential health-promoting molecule in man and animals. Nutr Res Rev. 2010 Dec;23(2):300-13. doi: 10.1017/S0954422410000193. Epub 2010 Aug 5.

    PubMed 20684797

  • Hanner P, Rask-Andersen H, Lange S, Jennische E. Antisecretory factor-inducing therapy improves the clinical outcome in patients with Meniere's disease. Acta Otolaryngol. 2010 Feb;130(2):223-7. doi: 10.3109/00016480903022842.

    PubMed 19479454

  • Zaman S, Mannan J, Lange S, Lonnroth I, Hanson LA. B 221, a medical food containing antisecretory factor reduces child diarrhoea: a placebo controlled trial. Acta Paediatr. 2007 Nov;96(11):1655-9. doi: 10.1111/j.1651-2227.2007.00488.x.

    PubMed 17937690

  • Laurenius A, Wangberg B, Lange S, Jennische E, Lundgren BK, Bosaeus I. Antisecretory factor counteracts secretory diarrhoea of endocrine origin. Clin Nutr. 2003 Dec;22(6):549-52. doi: 10.1016/s0261-5614(03)00057-8.

    PubMed 14613757

  • Al-Olama M, Lange S, Lonnroth I, Gatzinsky K, Jennische E. Uptake of the antisecretory factor peptide AF-16 in rat blood and cerebrospinal fluid and effects on elevated intracranial pressure. Acta Neurochir (Wien). 2015 Jan;157(1):129-37. doi: 10.1007/s00701-014-2221-7. Epub 2014 Sep 24.

    PubMed 25248325

  • Al-Olama M, Wallgren A, Andersson B, Gatzinsky K, Hultborn R, Karlsson-Parra A, Lange S, Hansson HA, Jennische E. The peptide AF-16 decreases high interstitial fluid pressure in solid tumors. Acta Oncol. 2011 Oct;50(7):1098-104. doi: 10.3109/0284186X.2011.562240. Epub 2011 Mar 4.

    PubMed 21375367

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Salovum in people with Head Trauma and Intensive Care Neurological Disorder, run by Peter Siesjö.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ICP (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03453749, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.

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