| - candidate number | 2401 |
| - NTR Number | NTR861 |
| - ISRCTN | ISRCTN88278819 |
| - Date ISRCTN created | 8-feb-2007 |
| - date ISRCTN requested | 7-feb-2007 |
| - Date Registered NTR | 11-jan-2007 |
| - Secondary IDs | HO82 |
| - Public Title | 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. |
| - Scientific Title | 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. |
| - ACRONYM | HOVON 82 |
| - hypothesis | PAS 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) studied | Hemato-oncological patients, Thrombocytopenia |
| - 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 | 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 |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-feb-2007 |
| - planned closingdate | 1-feb-2008 |
| - Target number of participants | 300 |
| - 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). |
| - Primary outcome | 1. 1 hour CCI |
| - Secondary outcome | 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 |
| - Timepoints | |
| - Trial web site | http://www.hovon.nl |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | M.D. J.L.H. Kerkhoffs |
| - CONTACT for SCIENTIFIC QUERIES | M.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 |
| - Publications | N/A |
| - Brief summary | Study 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) | |
| - RECORD | 11-jan-2007 - 9-feb-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl