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

Recruiting now

Conditions studied: Platelet Transfusion

In brief

* 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.

Key facts

Study ID

NCT07354672

Run by

Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen

People needed

850

Starts

2025-12-22

Expected to finish

2027-06-01

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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