Clinical Trial

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

Study acronym: INITIATE
Recruiting
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Summary
* Overall objective: to accumulate further experience with the use of pathogen-reduced platelet concentrates throughout the entire process chain from manufacture to clinical use of pathogen-reduced platelet concentrates and their efficacy and safety under real-world conditions. The study aims to better understand the impact of pathogen inactivation on the various steps of the overall supply chain in routine practice, whereby safety, measured in terms of the frequency of serious transfusion reactions and the type, imputability, and outcome of the reactions, is the primary endpoint. * Study product: Pathogen-reduced platelet concentrates. * Methodology: multi-center, open-label, prospective, non-interventional safety study.
Trial Details
NCT Number NCT07354672
Lead Sponsor Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen
Conditions Platelet Transfusion
Enrollment 850 participants
Start Date 2025-12-22
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-01-21