To assess the non-inferiority of PAS III-PC and PR-PAS III-PC compared to plasma-PC in terms of recovery, estimated by the 1-hour CCI post transfusion.
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1- hour CCI
Secondary outcome
- 24-hour CCI
- Bleeding grade 2 and higher
- Transfusion requirement, red cells and platelets
- Platelet transfusion interval
- Adverse transfusion reactions
Background summary
Extending storage for logistic purposes, combined with maintaining or even
improving the safety of platelet products, and maintaining clinical efficacy
are the main features in the development of new platelet products. In this
study protocol we aim to investigate transfusion efficacy of three different
platelet products: Plasma-PC, PAS III-PC and PR-PAS III-PC, combining extended
storage and the use of an additive solution, with or without treatment with a
photochemical pathogen reduction technique. Prior to the start of the clinical
study an in vitro study has been performed, showing that all study products
meet the minimal quality requirements. Both 1- and 24-hour CCI are commonly
used to evaluate platelet transfusions and, albeit not without discussion,
currently they are the only parameters in trigger based transfusion policies.
Refractoriness to platelet transfusions and bleeding complications are the main
clinical problems in intensively treated hemato-oncological patients and are
essential endpoints for transfusion studies.
Study objective
To assess the non-inferiority of PAS III-PC and PR-PAS III-PC compared to
plasma-PC in terms of recovery, estimated by the 1-hour CCI post transfusion.
Study design
The study is a prospective, randomized multicenter trial for the evaluation of
platelet products in hemato-oncological patients with thrombocytopenia or
expected to become thrombocytopenic caused by myelosuppressive therapy or
hemato-oncological related myelosuppression. 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 platelet concentrates (PAS III-PC)
Arm C: Pathogen reduced PAS III stored platelet concentrates (PR-PAS III-PC)
Intervention
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 platelet concentrates (PAS III-PC)
Arm C: Pathogen reduced PAS III stored platelet concentrates (PR-PAS III-PC)
Study burden and risks
absence (no other than the usual risks associated with platelet transfusions)
Postbus 7057
1007 MB Amsterdam
Nederland
Postbus 7057
1007 MB Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- Age * 18 years.
- Expected * 2 platelet transfusion requirements.
- Written informed consent.
- Having a hemato-oncological disease
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
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14989.098.06 |