* 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.
Patients ≥ 18 years
Patients who, based on clinical indications*, receive at least one platelet transfusion with a pathogen-reduced platelet concentrate for treatment of bleeding risk caused by severe thrombocytopenia resulting from impaired platelet production.
Known hypersensitivity to amotosalen HCl or psoralens. In this case, platelet concentrates treated with this pathogen inactivation method should not be used.
Known allergies of the recipient to human plasma proteins.
Known immune thrombocytopenia.
Thrombotic microangiopathy (thrombotic thrombocytopenic purpura; haemolytic uremic syn-drome).
Patients who, based on clinical indications\*, receive at least one platelet transfusion with a pathogen-reduced platelet concentrate for treatment of bleeding risk caused by severe thrombocytopenia resulting from impaired platelet production. (\* Taking into account the Cross-sectional Guidelines on the transfusion of blood components and plasma derivatives issued by the German Medical Association (Bundesärztekammer) in its current version.)
Cohort
Prospective
Pathogen-Reduced Platelet Concentrates
Biological/VaccinePathogen-reduced platelet concentrates which were either produced from 4, 5 or 8 buffy coats from whole blood donations or which were collected by apheresis.
Frequency of serious transfusion reactions after transfusion of pathogen-reduced platelet concentrates
Type, imputability and outcome of serious adverse reactions after transfusion of pathogen-reduced platelet concentrates.
Number of severe bleeding events
Number of severe bleeding events per patient
Frequency of severe bleeding events
Proportion of patients with at least one severe bleeding event
Clinical outcome of severe bleeding events
Outcome categorized as resolved, ongoing, or fatal
Overall survival
Time-to-event analysis of overall survival
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