* 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.
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
850
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.
Institut für Klinische Transfusionsmedizin (IKT) und DRK Blutspendedienst Baden-Württemberg-Hessen/ Transfusionsambulanz MVZ DRK-Blutspendedienst Ulm gGmbH
Ulm, Baden-Wurttemberg, Germany
RECRUITINGFrequency 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
Number of severe bleeding events
Number of severe bleeding events per patient
Time frame: Within 24 hours after platelet transfusion
Frequency of severe bleeding events
Proportion of patients with at least one severe bleeding event
Time frame: Within 24 hours after platelet transfusion
Clinical outcome of severe bleeding events
Outcome categorized as resolved, ongoing, or fatal
Time frame: Through study completion, up to 18 months
Overall survival
Time-to-event analysis of overall survival
Time frame: From date of enrollment until date of death from any cause, assessed up to 18 months
Cause of death
Categorized 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
Number of pathogen-reduced platelet concentrates manufactured per day
Time frame: Through study completion, up to 18 months
Manufacturing Workload for Pathogen-Reduced Platelet Concentrates
Cumulative hands-on manufacturing time per product
Time frame: Through study completion, up to 18 months
Manufacturing duration of pathogen-reduced platelet concentrates
Time from start to completion of manufacturing
Time frame: Through study completion, up to 18 months
Manufacturing failure rate
Number and proportion of manufacturing failures
Time frame: through study completion, up to 18 months
Availability of platelet concentrates for supply
Number of released platelet concentrates available for distribution
Time frame: 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
Time frame: 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
Time frame: Through study completion, up to 18 months
Discard rate of platelet concentrates
Number of platelet concentrates discarded
Time frame: Through study completion, up to 18 months
Platelet content of pathogen-reduced platelet concentrates
Platelet content per pathogen-reduced platelet concentrate
Time frame: 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
Time frame: 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
Time frame: Through study completion, up to 18 months
Residual leukocyte count
Residual leukocyte count per platelet concentrate
Time frame: Through study completion, up to 18 months
Out-of-Specification platelet concentrates
Proportion of platelet concentrates outside of predefined quality specifications
Time frame: Through study completion, up to 18 months
Transfusion reactions
Number of acute and delayed transfusion reactions
Time frame: Within 24 hours (acute) and up to 6 weeks (delayed) depending on transfusion reaction
HLA Alloimmunisation
Incidence of newly detected HLA antibodies
Time frame: Through study completion, up to 18 months
Composite thrombelastographhy coagulation index
Composite index derived from predefined thrombelastography parameters
Time frame: at least one measurement between 10 minutes and 24 hours post transfusion
Fibrinogen concentration
Change in fibrinogen concentration after platelet transfusion
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Through study completion, up to 18 months
Number of Plasma Transfusions per patient
Total number of plasma transfusions per patient
Time frame: Through study completion, up to 18 months
Cost of Platelet Concentrate products
Direct costs of platelet concentrate products
Time frame: through study completion, up to 18 months
Reimbursement of platelet concentrates within the DRG System
Reimbursement of platelet concentrates by health insurance providers
Time frame: 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.
Time frame: Through study completion, up to 18 months
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