Pathogen-Reduced Platelet Concentrates: Experience in Routine Practice in Germany
Pathogen-Reduced Platelet Concentrates: Experience In Routine Practice In Germany
Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen
850 participants
Dec 22, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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.
- (* 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.)
Exclusion Criteria7
- 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).
- Post-transfusion purpura.
- Heparin-induced thrombocytopenia.
- Congenital platelet function disorders, such as Glanzmann's thrombasthenia or Bernard- Souli-er syndrome
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Interventions
Pathogen-reduced platelet concentrates which were either produced from 4, 5 or 8 buffy coats from whole blood donations or which were collected by apheresis.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07354672