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Anti-secretory Factor as a Treatment for Adults With Severe Traumatic Head Injury (SATSWEDEN)

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ClinicalTrials.gov Identifier: NCT03453749
Recruitment Status : Withdrawn (New study in planning)
First Posted : March 5, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Siesjö, Skane University Hospital

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-cellular. The mechanisms by which edema arise are not fully known but it is proposed that inside the damaged brain, fluid will pass over the blood-brain barrier of the vessels into the extra-cellular space. The accumulation of fluid will lead to an increase in distance between the cell and its closest capillary, which may lead to energy failure and intra-cellular edema. The extra volume of the fluid leads to increased intracranial pressure, which in turn leads to an increase in blood pressure, aggravating the edema. In addition to the physiological changes that occur, the edema will be increased by the immunological response to the tissue damage with release of pro-inflammatory cytokines that give rise to both extra- and intra-cellular edema.

Today, no treatment has been proven efficient against traumatic brain edema. AF - anti-secretory factor is a 41 kDa protein that exists in humans and most animals. It was discovered due to its ability to inhibit experimental diarrhea.

AF has been proven to have an effect on Mb Menière and glaucoma. In animal models, AF has been proven efficient in reducing increased intracranial pressure caused by trauma and virus infection in the brain.

Salovum®, an egg yolk powder enriched in AF, is registered in the European Union as a medical food.

Methods: 5 adult patients with severe traumatic brain injury will be included in the trial via next of kin consent.

Medical interventions are protocol based. The protocol includes first, second and third treatment levels.

Patients included in the trial, will receive two micro-dialysis (MD) catheters in addition to standard treatment. One catheter will be placed in a separate burr hole close to the ICP and LICOX catheter, the other MD catheter will be placed in vicinity of the damaged barin tissue.

Patients will receive Salovum® 6 hours after trial inclusion. Patient dosage is 1g/kg body weight/24 hours, divided into 6 doses and administered orally, via tubing every 4 hours for 5 consecutive days.

Objective: Primary end-point is to investigate if Salovum® has a beneficiary effect on ICP.

Secondary endpoints are to investigate if Salovum® has a beneficiary effect on treatment intensity levels (TIL), brain-oxygenation, microdialysis bio-chemistry and cytokine expression in plasma and microdialysate.


Condition or disease Intervention/treatment Phase
Head Trauma Intensive Care Neurological Disorder Edema Brain Dietary Supplement: Salovum Phase 2

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, blood will be centrifuged and plasma will be frozen in -70° C for later analysis of cytokines.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 5 consecutive adult patients with severe head trauma will receive treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti-secretory Factor as a Treatment for Adults With Severe Traumatic Head Injury
Estimated Study Start Date : March 1, 2018
Actual Primary Completion Date : December 10, 2018
Actual Study Completion Date : December 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head Injuries

Arm Intervention/treatment
Salovum
Patients will be given Salovum 1g/kg body weight/24 hours, divided into 6 dosages and given during 5 consecutive days.
Dietary Supplement: Salovum
Salovum is freeze dried egg yolk, highly enriched with anti-secretory factor. Salovum is registered as a medical food by the EU




Primary Outcome Measures :
  1. ICP [ Time Frame: Up to 7 days ]
    Intracranial pressure in mm Hg


Secondary Outcome Measures :
  1. PtO2 [ Time Frame: Up to 7 days ]
    Brain tissue oxygenation in mm Hg

  2. Microdialysis biochemistry [ Time Frame: Up to 7 days ]
    Analysis of glucose, pyruvate and lactate from micro-dialysis fluid

  3. Cytokine expression [ Time Frame: Up to 7 days ]
    Analysis of cytokines from micro-dialysis fluid

  4. TIL [ Time Frame: Up to 7 days ]
    Treatment Intensity Level, scale 0-38



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult of either gender between 18 and 65 years.
  2. Non-penetrating, isolated severe traumatic brain injury
  3. GCS >3 and GCS<9 on admission or within 48 hours after injury*
  4. Admission to study hospital within 24 hours of injury*
  5. No known history of allergy to egg-protein
  6. Planned for intracranial pressure monitoring
  7. Absence of bilaterally dilated pupils
  8. 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 Criteria:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453749


Sponsors and Collaborators
Peter Siesjö
Investigators
Principal Investigator: David Cederberg, Consultant Dept of Neurosurgery, Skane University Hospital, Lund, Sweden

Publications:

Responsible Party: Peter Siesjö, Professor, Consultant, Skane University Hospital
ClinicalTrials.gov Identifier: NCT03453749     History of Changes
Other Study ID Numbers: Ethics reference: 2013/144
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peter Siesjö, Skane University Hospital:
Traumatic brain injury
Cerebral edema
Microdialysis
Inflammatory cytokines

Additional relevant MeSH terms:
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Antisecretory factor
Antidiarrheals
Gastrointestinal Agents