Clinical effectiveness and safety of pooled, random donor platelet concentrates, leucoreduced and stored up to seven days either in additive solution with and without pathogen reduction or plasma in hemato-oncological patients. (The TriPlate study)

Clinical effectiveness and safety of pooled, random donor platelet concentrates, leucoreduced and stored up to seven days either in additive solution with and without pathogen reduction or plasma in hemato-oncological patients. (The TriPlate study) - HOVON 82

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30251

Enrollment

300

Registered

2007-01-22

Start date

2007-01-31

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

thrombocytopenia

Interventions

In this trial patients will be randomized to receive one of three platelet products during one transfusion period: Arm A: Plasma stored platelet concentrates (Plasma-PC) Arm B: PAS III stored plat

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Known immunological refractoriness to platelet transfusions, i.e. HLA- and/or HPA-allo immunization and/or clinical relevant auto-antibodies. - Pregnancy (or lactating) - Previous inclusion in this study

Design outcomes

Primary

Measure	Time frame
1- hour CCI	—

Secondary

Measure	Time frame
- 24-hour CCI - Bleeding grade 2 and higher - Transfusion requirement, red cells and platelets - Platelet transfusion interval - Adverse transfusion reactions	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)