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

December 10, 2018 updated by: Peter Siesjö

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICP
Time Frame: Up to 7 days
Intracranial pressure in mm Hg
Up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PtO2
Time Frame: Up to 7 days
Brain tissue oxygenation in mm Hg
Up to 7 days
Microdialysis biochemistry
Time Frame: Up to 7 days
Analysis of glucose, pyruvate and lactate from micro-dialysis fluid
Up to 7 days
Cytokine expression
Time Frame: Up to 7 days
Analysis of cytokines from micro-dialysis fluid
Up to 7 days
TIL
Time Frame: Up to 7 days
Treatment Intensity Level, scale 0-38
Up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Siesjö

Investigators

  • Principal Investigator: David Cederberg, Consultant, Dept of Neurosurgery, Skane University Hospital, Lund, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2018

Primary Completion (Actual)

December 10, 2018

Study Completion (Actual)

December 10, 2018

Study Registration Dates

First Submitted

December 13, 2017

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

March 5, 2018

Study Record Updates

Last Update Posted (Actual)

December 12, 2018

Last Update Submitted That Met QC Criteria

December 10, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ethics reference: 2013/144

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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