Pathogen-Reduced Platelet Concentrates: Experience in Routine Practice in Germany
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pathogen-Reduced Platelet Concentrates.
- Who it may be relevant to
- Registry conditions: Platelet Transfusion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pathogen-Reduced Platelet Concentrates: Experience In Routine Practice In Germany
Overview
* 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.
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).
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.
Primary outcome measures
- Frequency of serious transfusion reactions after transfusion of pathogen-reduced platelet concentrates [Time frame: 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. [Time frame: Within 24 hours (acute) and up to 6 weeks (delayed) depending on transfusion reaction]
Secondary outcome measures (12)
- Number of severe bleeding events [Time frame: Within 24 hours after platelet transfusion]
- Frequency of severe bleeding events [Time frame: Within 24 hours after platelet transfusion]
- Clinical outcome of severe bleeding events [Time frame: Through study completion, up to 18 months]
- Overall survival [Time frame: From date of enrollment until date of death from any cause, assessed up to 18 months]
- Cause of death [Time frame: From date of enrollment until date of death from any cause, assessed up to 18 months.]
- Daily number of pathogen-reduced platelet concentrates manufactured [Time frame: Through study completion, up to 18 months]
- Manufacturing Workload for Pathogen-Reduced Platelet Concentrates [Time frame: Through study completion, up to 18 months]
- Manufacturing duration of pathogen-reduced platelet concentrates [Time frame: Through study completion, up to 18 months]
- Manufacturing failure rate [Time frame: through study completion, up to 18 months]
- Availability of platelet concentrates for supply [Time frame: Through study completion, up to 18 months]
- Time from product release to distribution [Time frame: Through study completion, up to 18 months]
- Shelf-life extension of non-pathogen-reduced platelet concentrates [Time frame: Through study completion, up to 18 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Institut für Klinische Transfusionsmedizin (IKT) und DRK Blutspendedienst Baden-Württember — Ulm
Identifiers
NCT: NCT07354672 · INITIATE