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Clinical effectiveness of standard versus pathogen-reduced buffy coat-derived platelet concentrates in plasma in hemato-oncological patients;Pathogen Reduction Evaluation & Predictive Analytical Rating Score (The PREPAReS Study)

Clinical effectiveness of standard versus pathogen-reduced buffy coat-derived platelet concentrates in plasma in hemato-oncological patients;Pathogen Reduction Evaluation & Predictive Analytical Rating Score (The PREPAReS Study) - The PREPAReS Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43833
Enrollment
400
Registered
2010-07-30
Start date
2011-03-23
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bleeding Thrombocytopenia

Interventions

one group of patients will receive platelet concentrates that have been pathogen-reduced, the other group will receive standard (untreated) platelet concentrates

Sponsors

Sanquin bloedvoorziening
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Age * 18 years. * Expected * 2 platelet transfusion requirements. * Having a hemato-oncological disease

Exclusion criteria

Exclusion criteria: * Micro-angiopathic thrombocytopenia (TTP, HUS) and ITP * Bleeding > grade 2 at randomization ( after treatment, the patient can be randomized in the study after 2 or more weeks after the last transfusion that was used to stop the bleeding) * Known immunological refractoriness to platelet transfusions. * HLA- and/or HPA-allo immunization and/or clinical relevant auto-antibodies. * Indications to use hyper-concentrated (plasma-reduced) platelet concentrates, i.e. patients with known severe allergic reactions and documented transfusion-associated circulatory overload (TACO) * Pregnancy (or lactating) * Prior treatment with pathogen-reduced blood products * Known allergy to riboflavin or its photoactive products

Design outcomes

Primary

MeasureTime frame
bleeding

Secondary

MeasureTime frame
platelet increments after transfusion, including correction for the body surface area percentage days with bleeding transfusion reactions number of red cell transfusions and platelet transfusions number of days between transfusions percentage of patients that develop antibodies relation between laboratory tests and clinical outcomes clinical factors that have an interaction with blood coagulation

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)