Status:
WITHDRAWN
Anti-secretory Factor as a Treatment for Adults With Severe Traumatic Head Injury
Lead Sponsor:
Peter Siesjö
Conditions:
Head Trauma
Intensive Care Neurological Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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-c...
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, bloo...
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
- 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.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03453749
Start Date
March 1 2018
End Date
December 10 2018
Last Update
December 12 2018
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