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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.


- candidate number2401
- NTR NumberNTR861
- ISRCTNISRCTN88278819
- Date ISRCTN created8-feb-2007
- date ISRCTN requested7-feb-2007
- Date Registered NTR11-jan-2007
- Secondary IDsHO82 
- Public TitleClinical 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.
- Scientific TitleClinical 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.
- ACRONYMHOVON 82
- hypothesisPAS III-PC and PR-PAS III-PC are non-inferior compared to plasma PC in terms of recovery, estimated by the 1-hour CCI post transfusion
- Healt Condition(s) or Problem(s) studiedHemato-oncological patients, Thrombocytopenia
- Inclusion criteria1. Age minimal 18 years; 2. Expected minimal 2 platelet transfusion requirements; 3. Written informed consent; 4. Having a hemato-oncological disease
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-feb-2007
- planned closingdate1-feb-2008
- Target number of participants300
- InterventionsAll 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).
- Primary outcome1. 1 hour CCI
- Secondary outcome1. 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
- Timepoints
- Trial web sitehttp://www.hovon.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESM.D. J.L.H. Kerkhoffs
- CONTACT for SCIENTIFIC QUERIESM.D. J.L.H. Kerkhoffs
- Sponsor/Initiator Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), Sanquin Blood Supply
- PublicationsN/A
- Brief summaryStudy phase: III Study objective: - Determination of non-inferiority of PR platelet concentrates (PR-PAS III-PC) and platelet concentrates in additive solution (PAS III-PC) compared to plasma (Plasma-PC), stored for 1-7 days, in terms of recovery, estimated by mean count corrected increment (CCI) at 1 hour - To assess the effectiveness in relation to storage time of the used platelet product - To evaluate whether clinical factors interact with the different study products leading to a difference in platelet refractoriness - To assess the 24 hour CCI - To assess the safety (bleeding complications and adverse transfusion reactions) - To assess transfusion requirement (red cells and platelets) - To assess the transfusion interval Patient population: - Hemato-oncological patients with thrombocytopenia, age minimal 18 years, without immunological refractoriness Study design: - A randomized multicenter non-inferiority trial with randomization between platelet transfusion support with Plasm-PC (Arm A), PAS III-PC (Arm B) or PR-PAS III-PC (Arm C) Duration of treatment: - Duration of study will be one transfusion period, which is defined as a period of 6 weeks or a maximum of 5 transfusions
- Main changes (audit trail)
- RECORD11-jan-2007 - 9-feb-2007


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