Skip to content

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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24058
Enrollment
300
Registered
2007-01-11
Start date
2007-02-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Hemato-oncological patients with thrombocytopenia and transfusion dependent

Interventions

All patients will be randomized to receive one of three platelet products during one transfusion period: 1. Arm A: Plasma stored platelet concentrates (Plasma-PC)
2. Arm B: PAS III stored platelet concentrates (PAS III-PC)
3. Arm C: Pathogen reduced PAS III stored platelet concentrates (PR-PAS III-PC).

Sponsors

Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data Center Erasmus MC - Daniel den Hoed Postbus 5201 3008 AE Rotterdam Tel: 010 4391568 Fax: 010 4391028 e-mail: hdc@erasmusmc.nl
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age minimal 18 years; 2. Expected minimal 2 platelet transfusion requirements; 3. Written informed consent; 4. Having a hemato-oncological disease

Exclusion criteria

Exclusion criteria: 1. Known immunological refractoriness to platelet transfusions, i.e. HLA- and/or HPA-allo immunization and/or clinical relevant auto-antibodies; 2. Pregnancy (or lactating); 3. Previous inclusion in this study

Design outcomes

Primary

MeasureTime frame
1. 1 hour CCI

Secondary

MeasureTime frame
1. 24 hour CCI 2. Bleeding grade minimal 2 (CTCAE v3.0) 3. Transfusion requirement, red cells and platelets 4. Platelet transfusion interval 5. Adverse transfusion reactions

Contacts

Public ContactJ.L.H. Kerkhoffs

HagaHospital, Leyweg 275

J.Kerkhoffs@hagaziekenhuis.nl+31 (0)70 3592004

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)