Status:

RECRUITING

Antisecretory Factor In Severe Traumatic Brain Injury

Lead Sponsor:

Peter Siesjö

Collaborating Sponsors:

Skane University Hospital

Lantmannen Medical AB

Conditions:

Traumatic Brain Injury

Eligibility:

All Genders

10-70 years

Phase:

PHASE2

Brief 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 b...

Detailed Description

Cerebral edema accounts for an essential part of the morbidity and mortality in severe traumatic brain injury but can also arise in other cerebral pathologies such as infectious and ischemic condition...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

March 10 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2025

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT04117672

Start Date

March 10 2020

End Date

June 30 2025

Last Update

October 1 2024

Active Locations (1)

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1

Skane University Hopsital

Lund, Sweden, 22185