RecruitingPhase 2NCT04117672

Antisecretory Factor In Severe Traumatic Brain Injury

Evaluation of Antisecretory Factor in Treatment of Severe Traumatic Brain Injury With Multimodal Monitoring


Sponsor

Peter Siesjö

Enrollment

20 participants

Start Date

Mar 10, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This study evaluates the addition of Salovum, an egg yolk powder enriched for antisecretory factor, to standard care of participants with severe traumatic brain injury. Half of the participants will be administered Salovum while the other half will be given a placebo egg yolk powder, not enriched for antisecretory factor. Intracranial pressure (ICP), partial brain oxygen pressure (PtbO2), microdialysis of metabolites and inflammatory mediators and trauma intensity level (TIL) will be assessed in all patients.


Eligibility

Min Age: 10 YearsMax Age: 70 Years

Inclusion Criteria3

  • Severe traumatic brain injury, Glasgow Outcome Scale (GCS) <9 at admission to NICU.
  • Clinical indication for insertion of intracranial pressure monitor, intracerebral oxygen pressure monitor and microdialysis catheter.
  • Consultation with relatives or consent from guardians.

Exclusion Criteria2

  • Known egg yolk allergy.
  • Unilateral or bilateral fixed and dilated pupil after initial operative intervention.

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Interventions

DIETARY_SUPPLEMENTSalovum

Active egg yolk powder

DIETARY_SUPPLEMENTPlacebo egg yolk powder

Normal egg yolk powder


Locations(1)

Skane University Hopsital

Lund, Sweden

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NCT04117672


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