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

NCT07354672 | Recruiting

• 1 other identifier: INITIATE
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Frequency of serious transfusion reactions after transfusion of pathogen-reduced platelet concentrates

  Within 24 hours (acute) and up to 6 weeks (delayed) depending on transfusion reaction

• Type, imputability and outcome of serious adverse reactions after transfusion of pathogen-reduced platelet concentrates.

  Within 24 hours (acute) and up to 6 weeks (delayed) depending on transfusion reaction

Secondary Outcomes (29)

• Number of severe bleeding events

  Within 24 hours after platelet transfusion

• Frequency of severe bleeding events

  Within 24 hours after platelet transfusion

• Clinical outcome of severe bleeding events

  Through study completion, up to 18 months

• Overall survival

  From date of enrollment until date of death from any cause, assessed up to 18 months

• Cause of death

  From date of enrollment until date of death from any cause, assessed up to 18 months.

Interventions

Pathogen-Reduced Platelet Concentrates BIOLOGICAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 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:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Study Officials

• 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

  STUDY DIRECTOR

Central Study Contacts

Simone Hoffmann, Dr. rer. nat.

CONTACT

+497311506897; initiate@blutspende.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 21, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

DE (1)