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

NCT07354672 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 850

Last updated 2026-01-21

No results posted yet for this 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.

Conditions

  • Platelet Transfusion

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

  • Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen

    lead OTHER

Principal Investigators

  • Hubert Schrezenmeier, Prof. Dr. med. · Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH (DRK-Blutspendedienst Baden-Württemberg Hessen gGmbH und Universitätsklinikum Ulm AöR). Institut für Transfusionsmedizin, Universität Ulm

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-22
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07354672 on ClinicalTrials.gov