Pathogen-Reduced Platelet Concentrates: Experience in Routine Practice in Germany

The safety of blood products has significantly improved over the past 30 years due to enhanced donor selection and more sensitive testing for infectious agents. Nevertheless, a residual risk remains, particularly the risk of bacterial contamination in platelet concentrates. To mitigate this, pathogen reduction methods and/or bacterial detection tests can be employed. In Germany, there is currently limited large-scale experience under real-world conditions regarding how pathogen reduction of platelet concentrates (PC) affects the various stages of the process chain from production, distribution through to the clinical application and its impact on safety and efficacy.To better understand the effects, the non-interventional post-authorization safety study INITIATE evaluates various aspects of pathogen-reduced, platelet concentrates across the entire process chain and compares results to historical data of standard, non-pathogen reduced PC. This project is a multi-center, open-label, prospective, non-interventional post-authorisation safety-study and is divided into two parts:

Part 1 focuses on product- and process-related objectives. It includes all pathogen-reduced PC units produced at participating manufacturing sites to analyse the product and supply-related endpoints including manufacturing data, quality control data, logistics and supply, safety and costs. Part 1 shall include data on 20.000 PC.

Part 2 includes a defined number of patients requiring PC transfusions at participating clinical study centers. It aims to collect data on safety (primary and co-primary endpoint: transfusion reactions (frequency, type, severity, imputability and outcome, according to CTCAE) and efficacy (bleeding, platelet increment (subgroup of patients), alloimmunization or platelet refractoriness). Part 2 shall include 850 patients (with an expected total number of 4.500 to 5.000 PC transfusions).

• Number of severe bleeding events [Срок оценки: Within 24 hours after platelet transfusion]
• Frequency of severe bleeding events [Срок оценки: Within 24 hours after platelet transfusion]
• Clinical outcome of severe bleeding events [Срок оценки: Through study completion, up to 18 months]
• Overall survival [Срок оценки: From date of enrollment until date of death from any cause, assessed up to 18 months]
• Cause of death [Срок оценки: From date of enrollment until date of death from any cause, assessed up to 18 months.]
• Daily number of pathogen-reduced platelet concentrates manufactured [Срок оценки: Through study completion, up to 18 months]
• Manufacturing Workload for Pathogen-Reduced Platelet Concentrates [Срок оценки: Through study completion, up to 18 months]
• Manufacturing duration of pathogen-reduced platelet concentrates [Срок оценки: Through study completion, up to 18 months]
• Manufacturing failure rate [Срок оценки: through study completion, up to 18 months]
• Availability of platelet concentrates for supply [Срок оценки: Through study completion, up to 18 months]
• Time from product release to distribution [Срок оценки: Through study completion, up to 18 months]
• Shelf-life extension of non-pathogen-reduced platelet concentrates [Срок оценки: Through study completion, up to 18 months]