Brain TraumaPhase 3SASATNCT03339505
Effect of Antisecretory Factor, Given as a Food Supplement to Adult Patients With Severe Traumatic Brain Injury
A Phase 3 study testing Salovum in people with Brain Trauma, run by Peter Siesjö at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain Trauma
- What is being tested?
- Salovum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Africa
- Study dates
- 17 Sep 2017to 10 Oct 2022
- Phase
- Phase 3
- 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
- 1. No consent 2. Systolic blood pressure below 90 mm Hg post resuscitation 3. Epidural hematoma with no other signs of intra-cranial injury 4. Penetrating injury 5. Non-fulfillment of inclusion criteria after screening and inclusion procedures.
- -
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Department of Neurosurgery, Tygerberg Hospital, Francie Van Zijl Dr
Cape Town, 7505
About this study
Official title: Salovum (Antisecretory Factor) in Patients With Severe Traumatic Brain Injury
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.
Read the detailed description
Treatment of increased ICP, using Anti-secretory Factor, in patients with severe head trauma Brain edema, defined as an increased fluid content in either the extracellular or intracellular space, arise in both trauma and in conjunction with other brain pathologies such as infectious diseases, intracranial tumors and ischemic events, i.e. stroke. The mechanisms underlying the formation of edema are not fully understood. In the injured brain, leakage over the blood brain-barrier arise which leads to transport of fluid from the blood to the extracellular space, causing an extracellular or vasogenic edema. Damage to cell membranes and disruption of cell function causes an intracellular or cytotoxic edema. Although one type of edema may predominate initially, one type most likely leads to another. In addition to the physiological, flow-related changes that arise, the edema is also worsened by the inflammatory response to damage. In the injured brain, disease associated molecular patterns (DAMP), and pro-inflammatory cytokines that can give rise to both intracellular and extracellular edema are released.
If the edema becomes expansive enough to give rise to a significant increase in intracranial pressure the circulation of the brain is threatened and surgical intervention inevitable. The most common procedure is hemicraniectomy, a procedure intended to add more space for the edematous brain to expand. The procedure itself is risky, and re-operations due to hematoma, CSF-leakage and more are common. Furthermore, it is not known how the procedure itself affects the brain in terms of increased edema, tearing of the brain etc.
Antisecretory factor, AF is a 41 kDa protein that exists in most mammals. It was first discovered due to its ability to inhibit experimental diarrhea. Endogenous AF secretion increases after exposure to bacterial toxins and an increase in AF secretion in combination with an inflammatory reaction may be a part of normal defense against the secretory and inflammatory component in diarrhea and other pathological processes involving membrane leakage and inflammation. AF has been shown to modulate pro-inflammatory and anti- inflammatory cytokine release. AF has also been shown to be effective against vertigo symptoms in Meniere's disease, which is believed to be caused by an abnormal collection of lymph around the balance nerve. AF and AF16 (the functional terminal 16 amino-acid peptide) have been tested in animal models of cerebral edema such as herpes encephalitis and traumatic brain injury with significant reduction of intracranial pressure, morbidity and mortality AF is commercially available for human use as Salovum®, an egg yolk powder B221® enriched for AF. It is available in pharmacies without prescription, but can also be prescribed as a dietary supplement in Sweden. Salovum® is classified as a "medical food" by the Swedish Pharmaceutical Agency and the European Union. Salovum® is currently registered in the Republic of South Africa.
Hypothesis Cerebral edema in traumatic brain injury is caused by inflammation triggered by tissue damage. The anti-secretory and anti-inflammatory compound Salovum® has the potential to counteract this and thus reduce cerebral edema in traumatic brain injury. Furthermore, the reduction of cerebral edema is hypothesized to decrease intracranial pressure, reduce the development of secondary brain damage and subsequently reduce treatment intensity levels and death.
Aims and Objectives Though, the number of patients with severe traumatic head injury in Sweden is decreasing and the need for a larger, randomized trial in a centre with large volumes of traumatic brain injury is needed The primary focus for scientific investigation is to evaluate if AF given as a dietary supplement (Salovum®) will reduce 30-day mortality in adult patients with severe traumatic brain injury. The secondary aims are to investigate whether AF will reduce intracranial pressure and treatment intensity levels - TIL, during intervention.
Methodology The outlined study is a phase-2, prospective, double-blinded, randomized, placebo-controlled trial. After inclusion patients will be randomized to active Salovum® or placebo egg powder treatment every 4th hour during 5 days. Treatment of patients will be according to current algorithms at the study site.
Study population 100 adult (age 18+) patients with severe traumatic brain injury, where ICP-monitoring is deemed necessary, will be included in the study.
Patient samples A venous whole blood sample will be drawn before and after treatment in all patients. The blood sample will be frozen and stored at the study site for further analysis.
Anticipated benefits In an ongoing Swedish study, preliminary results indicate that AF has a very potent ICP- lowering effect in patients with severe TBI and other pathologies encompassing cerebral edema, which might prove an effect on 30-day mortality in this trial.
- Conditions
- Brain Trauma
- Being tested
- Salovum, Placebo
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalovumDietary supplement
Dietary supplement with high concentration of anti-secretory factor
PlaceboDietary supplement
Placebo for Salovum
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day mortality
Death within 30 days of trauma
Measured: 30 days
Secondary outcomes (2)
TIL - Treatment Intensity Level
TIL is scored at the end of each 24 hour period in the NICU, where 0 is lowest intensity and 38 is maximum intensity
Measured: 0-5 days
ICP - Intracranial Pressure
ICP in mm Hg is recorded every hour during 0-5 days
Measured: 0-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start17 Sep 2017
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Brain TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blinded and prospective.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Siesjö
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stellenbosch
- Responsible party
- Sponsor-investigator, Peter Siesjö, Skane University Hospital
- Investigators
- Adriaan J Vlok, Professor, Principal investigator, University of Stellenbosch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339505
- Sponsor's protocol ID
- Ethics Reference #: M16/10/040
- Acronym
- SASAT
- Status last verified
- Oct 2022
- First submitted
- 20 Sep 2017
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24928077Zaman 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 24484450Leong 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 24294684Alam 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 21957667Ulgheri 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 20684797Hanner 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 19479454Zaman 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 17937690Laurenius 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 14613757Al-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 25248325Al-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 21375367Cederberg D, Harrington BM, Walker I, Grobler R, Naranbhai N, Jacobs RK, Visse E, Marklund N, Vlok AJ, Siesjo P. Salovum(R) reduces mortality in isolated severe traumatic brain injury: a randomized phase II trial. Brain. 2026 Sep 7:awag241. doi: 10.1093/brain/awag241. Online ahead of print.
PubMed 42705343Cederberg 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.
PubMed 35461285
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salovum (Antisecretory Factor) in Patients With Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03339505
- Acronym / sponsor ID
- SASAT / Ethics Reference #: M16/10/040
- Conditions
- Brain Trauma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Peter SiesjöUniversity, hospital or other
- Collaborators
- University of Stellenbosch
- Study start
- 17 Sep 2017 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Treatment of increased ICP, using Anti-secretory Factor, in patients with severe head trauma Brain edema, defined as an increased fluid content in either the extracellular or intracellular space, arise in both trauma and in conjunction with other brain pathologies such as infectious diseases, intracranial tumors and ischemic events, i.e. stroke. The mechanisms underlying the formation of edema are not fully understood. In the injured brain, leakage over the blood brain-barrier arise which leads to transport of fluid from the blood to the extracellular space, causing an extracellular or vasogenic edema. Damage to cell membranes and disruption of cell function causes an intracellular or cytotoxic edema. Although one type of edema may predominate initially, one type most likely leads to another. In addition to the physiological, flow-related changes that arise, the edema is also worsened by the inflammatory response to damage. In the injured brain, disease associated molecular patterns (DAMP), and pro-inflammatory cytokines that can give rise to both intracellular and extracellular edema are released.
If the edema becomes expansive enough to give rise to a significant increase in intracranial pressure the circulation of the brain is threatened and surgical intervention inevitable. The most common procedure is hemicraniectomy, a procedure intended to add more space for the edematous brain to expand. The procedure itself is risky, and re-operations due to hematoma, CSF-leakage and more are common. Furthermore, it is not known how the procedure itself affects the brain in terms of increased edema, tearing of the brain etc.
Antisecretory factor, AF is a 41 kDa protein that exists in most mammals. It was first discovered due to its ability to inhibit experimental diarrhea. Endogenous AF secretion increases after exposure to bacterial toxins and an increase in AF secretion in combination with an inflammatory reaction may be a part of normal defense against the secretory and inflammatory component in diarrhea and other pathological processes involving membrane leakage and inflammation. AF has been shown to modulate pro-inflammatory and anti- inflammatory cytokine release. AF has also been shown to be effective against vertigo symptoms in Meniere's disease, which is believed to be caused by an abnormal collection of lymph around the balance nerve. AF and AF16 (the functional terminal 16 amino-acid peptide) have been tested in animal models of cerebral edema such as herpes encephalitis and traumatic brain injury with significant reduction of intracranial pressure, morbidity and mortality AF is commercially available for human use as Salovum®, an egg yolk powder B221® enriched for AF. It is available in pharmacies without prescription, but can also be prescribed as a dietary supplement in Sweden. Salovum® is classified as a "medical food" by the Swedish Pharmaceutical Agency and the European Union. Salovum® is currently registered in the Republic of South Africa.
Hypothesis Cerebral edema in traumatic brain injury is caused by inflammation triggered by tissue damage. The anti-secretory and anti-inflammatory compound Salovum® has the potential to counteract this and thus reduce cerebral edema in traumatic brain injury. Furthermore, the reduction of cerebral edema is hypothesized to decrease intracranial pressure, reduce the development of secondary brain damage and subsequently reduce treatment intensity levels and death.
Aims and Objectives Though, the number of patients with severe traumatic head injury in Sweden is decreasing and the need for a larger, randomized trial in a centre with large volumes of traumatic brain injury is needed The primary focus for scientific investigation is to evaluate if AF given as a dietary supplement (Salovum®) will reduce 30-day mortality in adult patients with severe traumatic brain injury. The secondary aims are to investigate whether AF will reduce intracranial pressure and treatment intensity levels - TIL, during intervention.
Methodology The outlined study is a phase-2, prospective, double-blinded, randomized, placebo-controlled trial. After inclusion patients will be randomized to active Salovum® or placebo egg powder treatment every 4th hour during 5 days. Treatment of patients will be according to current algorithms at the study site.
Study population 100 adult (age 18+) patients with severe traumatic brain injury, where ICP-monitoring is deemed necessary, will be included in the study.
Patient samples A venous whole blood sample will be drawn before and after treatment in all patients. The blood sample will be frozen and stored at the study site for further analysis.
Anticipated benefits In an ongoing Swedish study, preliminary results indicate that AF has a very potent ICP- lowering effect in patients with severe TBI and other pathologies encompassing cerebral edema, which might prove an effect on 30-day mortality in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blinded and prospective.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Dietary Supplement: SalovumPatients in treatment group will receive Salovum according to g/kg body weight/24 hours/divided into 6 doses, during a maximum of 5 days |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPatients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- 1. No consent 2. Systolic blood pressure below 90 mm Hg post resuscitation 3. Epidural hematoma with no other signs of intra-cranial injury 4. Penetrating injury 5. Non-fulfillment of inclusion criteria after screening and inclusion procedures.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalovumDietary supplement with high concentration of anti-secretory factor | Dietary supplement | Treatment group |
| PlaceboPlacebo for Salovum | Dietary supplement | Placebo group |
Primary outcome
30 day mortality
Time frame: 30 days
Death within 30 days of trauma
2 secondary outcomes
TIL - Treatment Intensity Level
Time frame: 0-5 days
ICP - Intracranial Pressure
Time frame: 0-5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Background: PubMed 24928077Eide 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.
- Background: PubMed 24484450Zaman 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.
- Background: PubMed 24294684Leong 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.
- Background: PubMed 21957667Alam 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.
- Background: PubMed 20684797Ulgheri 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.
- Background: PubMed 19479454Hanner 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.
- Background: PubMed 17937690Zaman 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.
- Background: PubMed 14613757Laurenius 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.
- Background: PubMed 25248325Al-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.
- Background: PubMed 21375367Al-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.
- Derived from this study: PubMed 42705343Cederberg D, Harrington BM, Walker I, Grobler R, Naranbhai N, Jacobs RK, Visse E, Marklund N, Vlok AJ, Siesjo P. Salovum(R) reduces mortality in isolated severe traumatic brain injury: a randomized phase II trial. Brain. 2026 Sep 7:awag241. doi: 10.1093/brain/awag241. Online ahead of print.
- Derived from this study: PubMed 35461285Cederberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriaan J Vlok, Professor principal investigator
University of Stellenbosch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Salovum in people with Brain Trauma, run by Peter Siesjö at 1 site in South Africa.
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 2 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: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
30 day mortality (time frame: 30 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 NCT03339505, which also lists 12 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 Oct 2022.