Pathogen-Reduced Platelet Concentrates: 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
Patients will not be included if they fulfil at least one of the following exclusion criteria:
* 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
Primary outcome measure(s)
Frequency of serious transfusion reactions after transfusion of pathogen-reduced platelet concentrates — Within 24 hours (acute) and up to 6 weeks (delayed) depending on transfusion reaction
Type, imputability and outcome of serious adverse reactions after transfusion of pathogen-reduced platelet concentrates. — Within 24 hours (acute) and up to 6 weeks (delayed) depending on transfusion reaction
Trial sites (1)
Facility
City
Region
Status
Institut für Klinische Transfusionsmedizin (IKT) und DRK Blutspendedienst Baden-Württemberg-Hessen/ Transfusionsambulanz MVZ DRK-Blutspendedienst Ulm gGmbH
Ulm
Baden-Wurttemberg
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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