Pathogen-reduced platelet concentrates in routine care in Germany
Pathogen-Reduced Platelet Concentrates: Experience In Routine Practice In Germany
This project will test how platelet transfusions treated to remove pathogens perform and how safe they are for adults needing platelets because of low platelet counts.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 850 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen Academic / other |
| Locations | 1 site (Ulm, Baden-Wurttemberg) |
| Trial ID | NCT07354672 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) who, according to clinical guidelines, require at least one platelet transfusion with a pathogen-reduced platelet concentrate for bleeding risk due to severe thrombocytopenia from impaired platelet production are the intended participants.
Not a fit: Patients with listed exclusions—such as known hypersensitivity to amotosalen or psoralens, allergies to human plasma proteins, known immune thrombocytopenia, thrombotic microangiopathies, post-transfusion purpura, or other contraindications—will not be included and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this work could make platelet transfusions safer by reducing infectious and bacterial risks and by improving production and supply processes.
How similar studies have performed: Previous clinical trials and post-marketing experience show pathogen-reduction technologies can reduce bacterial contamination and transfusion-transmitted infections, though large-scale routine-practice data in Germany remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ulm, Baden-Wurttemberg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.