AATB Releases Sepsis Pilot Study Findings

AATB is pleased to share the Sepsis Pilot Study Report, a comprehensive analysis conducted by the AATB Physicians Council Sepsis Working Group. This study, which was submitted to the FDA on September 20, 2024, is a key component in the ongoing discussions regarding sepsis donor screening criteria, particularly in light of the pending FDA sepsis guidance document.

The pilot study was carried out between July 15, 2024, and August 5, 2024, with Medical Directors from seven tissue establishments participating. During this period, Medical Directors used a specially developed data collection tool alongside donor chart reviews, covering 486 de-identified donor records. The data collection and analysis performed by the WG offer crucial insights into the process of sepsis donor screening.

Included in this update are the following materials:

• Sepsis Pilot Study Report on Sepsis Criteria – The full report detailing the study and its findings.
• Appendix 1: Data Collection Tool (Spreadsheet) – A blank version of the spreadsheet used for data collection, including column headers.
• Appendix 2: Instructions for the Data Collection Tool – A guide for using the data collection tool.
• Pilot Study Overview PowerPoint – A high-level summary of the report, offering a concise version of the findings. 

Please note that Appendix 3, which contains the raw data from the study, will not be published publicly to maintain confidentiality.

This pilot study represents an important step in the collaborative effort to refine sepsis donor screening criteria, and AATB is proud to make this information available to our community. We encourage everyone to review the report and related materials as we continue to contribute to critical advancements in tissue banking and donor screening processes.