TRACK Study Update from The George Institute for Global Health	No images? Click here
Issue 24 – 10 March 2025

🎇 Welcome to TRACK 2025! 🎇

As we move into the next phase of the study, with most of our sites and countries now closed to recruitment, our focus shifts to follow-up. We deeply appreciate the time and dedication that all our sites and participants have contributed to the TRACK study. If there is anything we can do to further support you, please don’t hesitate to reach out. We look forward to navigating this next stage of the study together.

Overview of Recruitment and Outcomes 

Total Recruitment

Total Participants Experiencing 1st Primary Event

1st Primary Event

*All figures are as of 7 March 2025

✍️ Participant Follow Up ✍️

As our emphasis shifts to long-term follow up of participants please remember to continue to focus on the following:

 1. Participant retention: When in-person follow-ups are not feasible, consider offering alternative follow-up options. 

 2. Minimise treatment discontinuation:. Whenever possible, minimize extended treatment interruptions. If medically appropriate, consider resuming the study medication—even after an extended pause

 3. Reporting trial outcomes: Every participant and every outcome matter. Regularly reviewing medical records is essential to ensure no outcomes are overlooked. If you have any uncertainties, please do not hesitate to reach out to us.

📢 Important Reminder 📢

Special Message from our Medical Monitors 

We thank study sites for reporting “Incomplete dialysis vascular access thrombosis” which is a tertiary efficacy outcome in the TRACK trial.

We clarify that the following clinical situations do not meet criteria for this outcome:

 1. fistuloplasty alone, or

 2. balloon angioplasty of a fistula NOT involving thrombectomy, or

 3. central venous stenosis proximal to an AVF (in the absence of thrombosis)

Please note the below section from our project protocol on dialysis vascular access thrombosis 

👩💻 Database Update 👨💻

We recently made a minor update to the TRACK database to enhance functionality and improve data management. The key changes include:

 1. Study Medication Log – An additional page has been added to accommodate more log lines if needed.

 2. Protocol Deviations – Two new categories, “IMP” and “Safety,” have been introduced to provide more detailed classification.

If you have any questions or concerns regarding these updates, please don’t hesitate to reach out to your Global Team Member for further clarification or support.

💊 Investigational Medicinal Product (IMP) 💊

A sincere thank you to all sites for your patience during the recent IMP resupply process. This was a significant undertaking, as we worked to ensure all sites received new stock following the expiration of the current IMP batch. We recognize that, for some sites and countries, the process may not have been as smooth as anticipated, and we sincerely apologise for any challenges faced. Your patience and understanding throughout this transition have been greatly appreciated.

Now that all sites have received the new long-dated stock, your CRA will be reaching out with guidance on the proper destruction of any remaining short-dated IMP. Please note that there is a specific procedure that must be followed for IMP destruction. Do not proceed with destruction until you have consulted with your CRA.

📝 IBM Training Database Logins 📝

For any site staff who wish to train/practice data entry for the study, please visit the TRACK Training IBM Database by logging in with any of the following updated training accounts.

TRACK

Thank you for supporting the Track Trial.

To learn more please visit www.tracktrial.org

Warm regards,

The TRACK Trial team

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