Status:
COMPLETED
Effect of Antisecretory Factor, Given as a Food Supplement to Adult Patients With Severe Traumatic Brain Injury
Lead Sponsor:
Peter Siesjö
Collaborating Sponsors:
University of Stellenbosch
Conditions:
Brain Trauma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 gr...
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, aris...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
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Key Trial Info
Start Date :
September 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03339505
Start Date
September 17 2017
End Date
October 10 2022
Last Update
October 12 2022
Active Locations (1)
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1
Department of Neurosurgery, Tygerberg Hospital, Francie Van Zijl Dr
Cape Town, South Africa, 7505