SNOOPY

Please read the below information to learn more about the test involved in this sub-study:

•  A whole-body doppler ultrasound can estimate how fast blood flows by measuring the rate of change in its pitch (frequency).
• During a Doppler ultrasound, a technician trained in ultrasound imaging (sonographer/radiologist) presses a small hand-held device (transducer), about the size of a bar of soap, against the skin over the area of the body being examined, moving from one area to another as necessary.
• Doppler ultrasound has a gold standard performance for detecting blood clots in children and is easily accessible (can be conducted outside of radiology e.g. ward/intensive care unit).
• The body sites for ultrasound will be done in order of priority and this scan can be stopped at any time.
• The ultrasound will be conducted as early as possible after enrolment into the SNAP platform and/or registry.
• A second ultrasound will occur within 72 hours after the initial scan if results were negative from the first scan AND:

               (1) The Staph aureus bloodstream infection is ongoing

                     OR

               (2) A new focus of infection is detected via imaging or clinically.

• Standard of care treatment will be prioritised over this ultrasound.
• A single additional optional blood test (ClotPro) will be taken with routine blood testing to see how your child's clotting system works.
• All routine tests will be prioritised over this optional blood test

Benefits

• Your child may not benefit from this study, but it is possible that the results from this sub study will help us better understand and detect blood clots in children who have Staph aureus bloodstream infections
• Earlier detection of a blood clot that can be associated with SAB may facilitate earlier clot treatment
• Research like this may also help to improve the care and diagnosis of blood clots in children with SAB in the future

Risks

•  The risks of participating in this sub study are low; there are minimal to no side effects of the doppler ultrasound.
• If your child has any side effects related to the ultrasound, or you would like to discuss any other concerns, please talk to your child’s doctor and the SNOOPY study investigators
• If a blood clot is detected, your child may or may not be recommended for anti-blood clot medication depending on your treating team’s care plan. This is because each child’s clinical needs are different, and the decision needs to be tailored to your child’s health, medical history, and best interests.

Additional data collected for this sub study will be stored in a separate database to the SNAP Trial.

This additional data includes:

•  Risk factors for thrombosis
• Information relating to any blood clot(s) discovered, including association with any intravenous catheter going into the vein or if it is next to a site of SAB infection.
• Any treatments, assessments or procedures the treating doctor performs if any blood clots are discovered.

All information collected for this sub study will be deidentified, meaning it will not be able to identify you.

The database is housed at the University of Melbourne, is password encrypted, and only accessible to the sub-study investigators.

Your information will be stored for at least 15 years after this sub study is completed.

You can withdraw from the entire study or just the optional blood test component at any time, just notify a member of your child’s treating team and study investigators.

If you withdraw, we will keep any information we have collected about your child up until you withdraw. If you do not agree with this, you should not join the study.

‍Name: Dr Anita Campbell (study doctor and lead investigator)

Email: Anita.campbell2@health.wa.gov.au

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Name: Miss Keerthi Anpalagan (Study Investigator)

Email: Keerthi.anpalagan@telethonkids.org.au

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