Pathogen-reduced platelet concentrates in routine care in Germany

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, open-label, prospective, non-interventional post-authorization safety project collects real-world data on pathogen-reduced platelet concentrates across the full supply chain from manufacture to clinical use in Germany. It is divided into two parts: Part 1 collects product- and process-level data on approximately 20,000 platelet concentrate units to analyze manufacturing, quality control, logistics, safety, and costs, and Part 2 enrolls patients receiving pathogen-reduced platelet transfusions to capture clinical outcomes. The primary endpoint is safety measured by the frequency, type, imputability, and outcome of serious transfusion reactions, with comparisons to historical data from standard, non-pathogen reduced platelets. Data are gathered during routine care at participating blood service and transfusion centers without changing standard clinical practice.

Why it matters

Who can join: the full rules

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

Where it's running

• Institut für Klinische Transfusionsmedizin (IKT) und DRK Blutspendedienst Baden-Württemberg-Hessen/ Transfusionsambulanz MVZ DRK-Blutspendedienst Ulm gGmbH
  Ulm, Baden-Wurttemberg, Germany Recruiting

Study contacts

• Study coordinator: Simone Hoffmann, Dr. rer. nat.
• Email: initiate@blutspende.de
• Phone: +497311506897

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.