Pathogen-Reduced Platelet Concentrates: Experience in Routine Practice in Germany (INITIATE)

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

• 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.

Study Overview

• Status: Recruiting
• Conditions: Platelet Transfusion
• Intervention / Treatment: Biological: Pathogen-Reduced Platelet Concentrates

Detailed Description

The safety of blood products has significantly improved over the past 30 years due to enhanced donor selection and more sensitive testing for infectious agents. Nevertheless, a residual risk remains, particularly the risk of bacterial contamination in platelet concentrates. To mitigate this, pathogen reduction methods and/or bacterial detection tests can be employed. In Germany, there is currently limited large-scale experience under real-world conditions regarding how pathogen reduction of platelet concentrates (PC) affects the various stages of the process chain from production, distribution through to the clinical application and its impact on safety and efficacy.To better understand the effects, the non-interventional post-authorization safety study INITIATE evaluates various aspects of pathogen-reduced, platelet concentrates across the entire process chain and compares results to historical data of standard, non-pathogen reduced PC. This project is a multi-center, open-label, prospective, non-interventional post-authorisation safety-study and is divided into two parts:

Part 1 focuses on product- and process-related objectives. It includes all pathogen-reduced PC units produced at participating manufacturing sites to analyse the product and supply-related endpoints including manufacturing data, quality control data, logistics and supply, safety and costs. Part 1 shall include data on 20.000 PC.

Part 2 includes a defined number of patients requiring PC transfusions at participating clinical study centers. It aims to collect data on safety (primary and co-primary endpoint: transfusion reactions (frequency, type, severity, imputability and outcome, according to CTCAE) and efficacy (bleeding, platelet increment (subgroup of patients), alloimmunization or platelet refractoriness). Part 2 shall include 850 patients (with an expected total number of 4.500 to 5.000 PC transfusions).

• Study Type: Observational
• Enrollment (Estimated): 850

Contacts and Locations

• Study Contact: Name: Simone Hoffmann, Dr. rer. nat.; Phone Number: +497311506897; Email: initiate@blutspende.de

Study Locations

• Germany
  • Baden-Wurttemberg
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Recruiting
      • Institut für Klinische Transfusionsmedizin (IKT) und DRK Blutspendedienst Baden-Württemberg-Hessen/ Transfusionsambulanz MVZ DRK-Blutspendedienst Ulm gGmbH
      • Contact: Hubert Schrezenmeier, Prof Dr med.; Phone Number: +49731150500; Email: h.schrezenmeier@blutspende.de
      • Principal Investigator: Sixten Körper, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of severe bleeding events	Number of severe bleeding events per patient	Within 24 hours after platelet transfusion
Frequency of severe bleeding events	Proportion of patients with at least one severe bleeding event	Within 24 hours after platelet transfusion
Clinical outcome of severe bleeding events	Outcome categorized as resolved, ongoing, or fatal	Through study completion, up to 18 months
Overall survival	Time-to-event analysis of overall survival	From date of enrollment until date of death from any cause, assessed up to 18 months
Cause of death	Categorized cause of death	From date of enrollment until date of death from any cause, assessed up to 18 months.
Daily number of pathogen-reduced platelet concentrates manufactured	Number of pathogen-reduced platelet concentrates manufactured per day	Through study completion, up to 18 months
Manufacturing Workload for Pathogen-Reduced Platelet Concentrates	Cumulative hands-on manufacturing time per product	Through study completion, up to 18 months
Manufacturing duration of pathogen-reduced platelet concentrates	Time from start to completion of manufacturing	Through study completion, up to 18 months
Manufacturing failure rate	Number and proportion of manufacturing failures	through study completion, up to 18 months
Availability of platelet concentrates for supply	Number of released platelet concentrates available for distribution	Through study completion, up to 18 months
Time from product release to distribution	Time from release of platelet concentrates to transfer to the distribution department	Through study completion, up to 18 months
Shelf-life extension of non-pathogen-reduced platelet concentrates	Number of non-pathogen-inactivated platelet concentrates requiring shelf-life extension	Through study completion, up to 18 months
Discard rate of platelet concentrates	Number of platelet concentrates discarded	Through study completion, up to 18 months
Platelet content of pathogen-reduced platelet concentrates	Platelet content per pathogen-reduced platelet concentrate	Through study completion, up to 18 months
Bacterial contamination of pathogen-reduced platelet concentrates	Presence or absence of baterial contamination per platelet concentrates as determined by routine quality control testing	Through study completion, up to 18 months
pH of pathogen-reduced platelet concentrats at end of sheld life	pH value measured at the end of shelf life	Through study completion, up to 18 months
Residual leukocyte count	Residual leukocyte count per platelet concentrate	Through study completion, up to 18 months
Out-of-Specification platelet concentrates	Proportion of platelet concentrates outside of predefined quality specifications	Through study completion, up to 18 months
Transfusion reactions	Number of acute and delayed transfusion reactions	Within 24 hours (acute) and up to 6 weeks (delayed) depending on transfusion reaction
HLA Alloimmunisation	Incidence of newly detected HLA antibodies	Through study completion, up to 18 months
Composite thrombelastographhy coagulation index	Composite index derived from predefined thrombelastography parameters	at least one measurement between 10 minutes and 24 hours post transfusion
Fibrinogen concentration	Change in fibrinogen concentration after platelet transfusion	at least one measurement between 10 minutes and 24 hours post transfusion
Time to next platelet concentrate transfusion under routine conditions	Time interval to subsequent platelet transfusion	From completion of first transfusion until the next transfusion under routine clinical practice, assessed up to 18 months
Number of platelet concentrates per patient	Total number of platelet transfusions per patients	through study completion, up to 18 months
Number of Red Blood Cell Transfusions per patient	Total number of packed red blood cell transfusions per patient.	Through study completion, up to 18 months
Number of Plasma Transfusions per patient	Total number of plasma transfusions per patient	Through study completion, up to 18 months
Cost of Platelet Concentrate products	Direct costs of platelet concentrate products	through study completion, up to 18 months
Reimbursement of platelet concentrates within the DRG System	Reimbursement of platelet concentrates by health insurance providers	Through study completion, up to 18 months
User satisfaction at the various stages of production, distribution and application of platelet concentrates	User satisfaction at the various stages of production, distribution and application of platelet concentrates, measured on a scale of 0 to 10, with 10 representing best result, based on questionnaires at the start of the observational study, after three and six months and at the end of the study.	Through study completion, up to 18 months

Collaborators and Investigators

• Sponsor: Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): December 22, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: INITIATE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No