MedTrace Logo

Effect of Antisecretory Factor, Given as a Food Supplement to Adult Patients With Severe Traumatic Brain Injury

NCT03339505 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-10-12

No results posted yet for this study

Summary

The present trial intends to assess whether Salovum®, an egg powder enriched for antisecretory factor given to patients with severe traumatic brain injury will improve outcome compared to a control group given placebo egg powder.

100 patients with GCS\<9 will be enrolled and randomised to active or placebo treatment during maximum 5 days. Salovum® or placebo will be administered orally by nasogastric feeding tubes.

Primary endpoint will be overall 30 data mortality. Secondary endpoints will be intracranial pressure and treatment intensity level.

Conditions

  • Brain Trauma

Interventions

DIETARY_SUPPLEMENT

Salovum

Dietary supplement with high concentration of anti-secretory factor

DIETARY_SUPPLEMENT

Placebo

Placebo for Salovum

Sponsors & Collaborators

  • University of Stellenbosch

    collaborator OTHER

  • Peter Siesjö

    lead OTHER

Principal Investigators

  • Adriaan J Vlok, Professor · University of Stellenbosch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-17
Primary Completion
2022-10-10
Completion
2022-10-10

Countries

  • South Africa

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03339505 on ClinicalTrials.gov