NCT03339505

Brief Summary

The present trial intends to assess whether Salovum®, an egg powder enriched for antisecretory factor given to patients with severe traumatic brain injury will improve outcome compared to a control group given placebo egg powder. 100 patients with GCS\<9 will be enrolled and randomised to active or placebo treatment during maximum 5 days. Salovum® or placebo will be administered orally by nasogastric feeding tubes. Primary endpoint will be overall 30 data mortality. Secondary endpoints will be intracranial pressure and treatment intensity level.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2017

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

5.1 years

First QC Date

September 20, 2017

Last Update Submit

October 10, 2022

Conditions

Brain Trauma

Outcome Measures

Primary Outcomes (1)

  • 30 day mortality

    Death within 30 days of trauma

    30 days

Secondary Outcomes (2)

  • TIL - Treatment Intensity Level

    0-5 days

  • ICP - Intracranial Pressure

    0-5 days

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Patients in treatment group will receive Salovum according to g/kg body weight/24 hours/divided into 6 doses, during a maximum of 5 days

Dietary Supplement: Salovum

Placebo group

PLACEBO COMPARATOR

Patients in treatment group will receive Placebo (egg yolk powder) according to g/kg body weight/24 hours/divided into 6 doses, during a maximum of 5 days

Dietary Supplement: Placebo

Interventions

SalovumDIETARY_SUPPLEMENT

Dietary supplement with high concentration of anti-secretory factor

Treatment group
PlaceboDIETARY_SUPPLEMENT

Placebo for Salovum

Placebo group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Tygerberg Hospital, Francie Van Zijl Dr

Cape Town, 7505, South Africa

Location

Related Publications (11)

  • 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.

    PMID: 24928077BACKGROUND

  • 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.

    PMID: 24484450BACKGROUND

  • 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.

    PMID: 24294684BACKGROUND

  • 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.

    PMID: 21957667BACKGROUND

  • 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.

    PMID: 20684797BACKGROUND

  • 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.

    PMID: 19479454BACKGROUND

  • 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.

    PMID: 17937690BACKGROUND

  • 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.

    PMID: 14613757BACKGROUND

  • 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.

    PMID: 25248325BACKGROUND

  • 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.

    PMID: 21375367BACKGROUND

  • Cederberg D, Harrington BM, Vlok AJ, Siesjo P. 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. Trials. 2022 Apr 23;23(1):340. doi: 10.1186/s13063-022-06275-z.

    PMID: 35461285DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Adriaan J Vlok, Professor

    University of Stellenbosch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blinded until the end of the trial. Unmasking will take place once all patients are included and the trial is concluded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double blinded and prospective.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Consultant

Study Record Dates

First Submitted

September 20, 2017

First Posted

November 13, 2017

Study Start

September 17, 2017

Primary Completion

October 10, 2022

Study Completion

October 10, 2022

Last Updated

October 12, 2022

Record last verified: 2022-10

Locations

ZA(1)