AATB Releases Updated Sepsis Pilot Study Report

AATB is pleased to announce the release of an updated version of the Sepsis Pilot Study Report, originally published in September 2024. This updated report includes the same data as the original pilot study, but presents the results using statistical methods aligned with professional standards, providing a clearer and more structured presentation of the findings.

The pilot study, conducted between July 15, 2024, and August 5, 2024, involved Medical Directors from seven tissue establishments reviewing 486 de-identified donor records using a specially developed data collection tool. The study continues to serve as a key resource in ongoing discussions about sepsis donor screening criteria, particularly in the context of the pending FDA sepsis guidance. 

What’s included in the updated release:

• Updated Sepsis Pilot Study Report on Sepsis Criteria – Reformatted and analyzed using standard statistical approaches; includes a new table summarizing sentinel tissue-transmission events published in MMWR since 1979.
• Appendix 1: Data Collection Tool (Spreadsheet) – Unchanged; a blank version of the spreadsheet used for data collection, including column headers.
• Appendix 2: Instructions for the Data Collection Tool – Unchanged; a guide for using the data collection tool.

Important note: The original September 2024 report remains available for reference, but is no longer the most current version. Users are encouraged to consult the updated report for the latest presentation of the study findings. As before, Appendix 3, which contains the raw data from the study, will not be published publicly to maintain confidentiality.

This update reflects AATB’s ongoing commitment to transparency and scientific rigor in tissue banking and donor screening processes. We encourage our community to review the updated report and related materials as part of continued efforts to refine sepsis donor screening criteria.