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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| 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 |
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Inclusion Criteria:
(* 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:
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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.)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simone Hoffmann, Dr. rer. nat. | Contact | +497311506897 | initiate@blutspende.de |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Klinische Transfusionsmedizin (IKT) und DRK Blutspendedienst Baden-Württemberg-Hessen/ Transfusionsambulanz MVZ DRK-Blutspendedienst Ulm gGmbH | Recruiting | Ulm | Baden-Wurttemberg | 89081 | Germany |
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| 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 |
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