Platelet TransfusionINITIATENCT07354672
Pathogen-Reduced Platelet Concentrates: Experience in Routine Practice in Germany
An observational study of Platelet Transfusion, run by Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Transfusion
- What is being tested?
- Pathogen-Reduced Platelet Concentrates
- How many people
- 850 participants
- Where
- 1 siteGermany
- Study dates
- 22 Dec 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.)
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Institut für Klinische Transfusionsmedizin (IKT) und DRK Blutspendedienst Baden-Württemberg-Hessen/ Transfusionsambulanz MVZ DRK-Blutspendedienst Ulm gGmbH
Ulm, Baden-Wurttemberg, 89081
Hubert Schrezenmeier, Prof Dr med., +49731150500, h.schrezenmeier@blutspende.de
Sixten Körper, Dr. med.
About this study
Official title: 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.
Read the 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).
- Conditions
- Platelet Transfusion
- Being tested
- Pathogen-Reduced Platelet Concentrates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathogen-Reduced Platelet ConcentratesBiological
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of serious transfusion reactions after transfusion of pathogen-reduced platelet concentrates
Measured: 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.
Measured: Within 24 hours (acute) and up to 6 weeks (delayed) depending on transfusion reaction
Secondary outcomes (29)
Number of severe bleeding events
Number of severe bleeding events per patient
Measured: Within 24 hours after platelet transfusion
Frequency of severe bleeding events
Proportion of patients with at least one severe bleeding event
Measured: Within 24 hours after platelet transfusion
Clinical outcome of severe bleeding events
Outcome categorized as resolved, ongoing, or fatal
Measured: Through study completion, up to 18 months
Overall survival
Time-to-event analysis of overall survival
Measured: From date of enrollment until date of death from any cause, assessed up to 18 months
Cause of death
Categorized cause of death
Measured: 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
Measured: Through study completion, up to 18 months
Manufacturing Workload for Pathogen-Reduced Platelet Concentrates
Cumulative hands-on manufacturing time per product
Measured: Through study completion, up to 18 months
Manufacturing duration of pathogen-reduced platelet concentrates
Time from start to completion of manufacturing
Measured: Through study completion, up to 18 months
Manufacturing failure rate
Number and proportion of manufacturing failures
Measured: through study completion, up to 18 months
Availability of platelet concentrates for supply
Number of released platelet concentrates available for distribution
Measured: 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
Measured: 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
Measured: Through study completion, up to 18 months
Discard rate of platelet concentrates
Number of platelet concentrates discarded
Measured: Through study completion, up to 18 months
Platelet content of pathogen-reduced platelet concentrates
Platelet content per pathogen-reduced platelet concentrate
Measured: 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
Measured: 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
Measured: Through study completion, up to 18 months
Residual leukocyte count
Residual leukocyte count per platelet concentrate
Measured: Through study completion, up to 18 months
Out-of-Specification platelet concentrates
Proportion of platelet concentrates outside of predefined quality specifications
Measured: Through study completion, up to 18 months
Transfusion reactions
Number of acute and delayed transfusion reactions
Measured: Within 24 hours (acute) and up to 6 weeks (delayed) depending on transfusion reaction
HLA Alloimmunisation
Incidence of newly detected HLA antibodies
Measured: Through study completion, up to 18 months
Composite thrombelastographhy coagulation index
Composite index derived from predefined thrombelastography parameters
Measured: at least one measurement between 10 minutes and 24 hours post transfusion
Fibrinogen concentration
Change in fibrinogen concentration after platelet transfusion
Measured: 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
Measured: 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
Measured: 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.
Measured: Through study completion, up to 18 months
Number of Plasma Transfusions per patient
Total number of plasma transfusions per patient
Measured: Through study completion, up to 18 months
Cost of Platelet Concentrate products
Direct costs of platelet concentrate products
Measured: through study completion, up to 18 months
Reimbursement of platelet concentrates within the DRG System
Reimbursement of platelet concentrates by health insurance providers
Measured: 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.
Measured: Through study completion, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start22 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet TransfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubert Schrezenmeier, Prof. Dr. med., Study director, Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH (DRK-Blutspendedienst Baden-Württemberg Hessen gGmbH und Universitätsklinikum Ulm AöR). Institut für Transfusionsmedizin, Universität Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354672
- Sponsor's protocol ID
- INITIATE
- Acronym
- INITIATE
- Status last verified
- Jan 2026
- First submitted
- 26 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogen-Reduced Platelet Concentrates: Experience In Routine Practice In Germany
- ClinicalTrials.gov ID
- NCT07354672
- Acronym / sponsor ID
- INITIATE / INITIATE
- Conditions
- Platelet Transfusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-HessenUniversity, hospital or other
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.)
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pathogen-Reduced Platelet ConcentratesPathogen-reduced platelet concentrates which were either produced from 4, 5 or 8 buffy coats from whole blood donations or which were collected by apheresis. | Biological | – |
Primary outcome
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
29 secondary outcomes
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
Discard rate of platelet concentrates
Time frame: Through study completion, up to 18 months
Platelet content of pathogen-reduced platelet concentrates
Time frame: Through study completion, up to 18 months
Bacterial contamination of pathogen-reduced platelet concentrates
Time frame: Through study completion, up to 18 months
pH of pathogen-reduced platelet concentrats at end of sheld life
Time frame: Through study completion, up to 18 months
Residual leukocyte count
Time frame: Through study completion, up to 18 months
Out-of-Specification platelet concentrates
Time frame: Through study completion, up to 18 months
Transfusion reactions
Time frame: Within 24 hours (acute) and up to 6 weeks (delayed) depending on transfusion reaction
HLA Alloimmunisation
Time frame: Through study completion, up to 18 months
Composite thrombelastographhy coagulation index
Time frame: at least one measurement between 10 minutes and 24 hours post transfusion
Fibrinogen concentration
Time frame: at least one measurement between 10 minutes and 24 hours post transfusion
Time to next platelet concentrate transfusion under routine conditions
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
Time frame: through study completion, up to 18 months
Number of Red Blood Cell Transfusions per patient
Time frame: Through study completion, up to 18 months
Number of Plasma Transfusions per patient
Time frame: Through study completion, up to 18 months
Cost of Platelet Concentrate products
Time frame: through study completion, up to 18 months
Reimbursement of platelet concentrates within the DRG System
Time frame: Through study completion, up to 18 months
User satisfaction at the various stages of production, distribution and application of platelet concentrates
Time frame: Through study completion, up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hubert Schrezenmeier, Prof. Dr. med. study director
Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH (DRK-Blutspendedienst Baden-Württemberg Hessen gGmbH und Universitätsklinikum Ulm AöR). Institut für Transfusionsmedizin, Universität Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Transfusion, run by Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone Hoffmann, Dr. rer. nat. (+497311506897, initiate@blutspende.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.