Actively Recruiting

Age: 18Years +
All Genders
NCT07354672

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

Led by Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen · Updated on 2026-01-21

850

Participants Needed

1

Research Sites

75 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

* 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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Patients who need at least one platelet transfusion with pathogen-reduced platelet concentrates for bleeding risk caused by severe thrombocytopenia due to impaired platelet production
  • Transfusion indication based on current German Medical Association guidelines
Not Eligible

You will not qualify if you...

  • Known hypersensitivity to amotosalen HCl or psoralens
  • Known allergies to human plasma proteins
  • Diagnosis of immune thrombocytopenia
  • Presence of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura or hemolytic uremic syndrome
  • History of post-transfusion purpura
  • Diagnosis of heparin-induced thrombocytopenia
  • Congenital platelet function disorders such as Glanzmann's thrombasthenia or Bernard-Soulier syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institut für Klinische Transfusionsmedizin (IKT) und DRK Blutspendedienst Baden-Württemberg-Hessen/ Transfusionsambulanz MVZ DRK-Blutspendedienst Ulm gGmbH

Ulm, Baden-Wurttemberg, Germany, 89081

Actively Recruiting

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Research Team

S

Simone Hoffmann, Dr. rer. nat.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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