Pathogen-Reduced Platelet Concentrates: Experience in Routine Practice in Germany (NCT07354672) | Clinical Trial Compass
RecruitingNot Applicable
Pathogen-Reduced Platelet Concentrates: Experience in Routine Practice in Germany
Germany850 participantsStarted 2025-12-22
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of serious transfusion reactions after transfusion of pathogen-reduced platelet concentrates
Timeframe: Within 24 hours (acute) and up to 6 weeks (delayed) depending on transfusion reaction
2
Type, imputability and outcome of serious adverse reactions after transfusion of pathogen-reduced platelet concentrates.
Timeframe: Within 24 hours (acute) and up to 6 weeks (delayed) depending on transfusion reaction