|- candidate number||6714|
|- NTR Number||NTR2106|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-nov-2009|
|- Secondary IDs||ABR30643 |
|- Public Title||The PREPAReS Study: Pathogen Reduction Evaluation & Predictive Analytical Rating Score.|
|- Scientific Title||Clinical effectiveness of standard versus pathogen-reduced buffy coat-derived platelet concentrates in plasma in hemato oncological patients.|
|- ACRONYM||The PREPAReS Study: Pathogen Reduction Evaluation & Predictive Analytical Rating Score|
|- hypothesis||Non-inferiority (defined as < 12.5% increase) of pooled buffy coat-derived PR platelet concentrates (PR-plasma-PCs) compared to plasma (plasma-PCs) in terms of clinical efficacy determined by WHO grade ≥ 2 bleeding complications.|
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||1. Age ≥ 18 years; |
2. Expected ≥ 2 platelet transfusion requirements;
3. Signed informed consent;
4. Having hemato oncological disease including those who undergo myelo ablative allogeneic stem cell transplant therapy.
|- Exclusion criteria||1. Micro-angiopathic thrombocytopenia (TTP, HUS) and ITP;|
2. Bleeding > grade 2 at randomization ( after treatment, the patient can be randomized in the study after 2 or more weeks after the last transfusion that was used to stop the bleeding);
3. Known immunological refractoriness to platelet transfusions;
4. HLA- and/or HPA-allo immunization and/or clinical relevant auto-antibodies;
5. Indications to use hyper-concentrated (plasma-reduced) platelet concentrates, i.e. patients with known severe allergic reactions and documented transfusion-associated circulatory overload (TACO);
6. Pregnancy (or lactating);
7. Prior treatment with pathogen-reduced blood products;
8. Known allergy to riboflavin or its photoactive products.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2010|
|- planned closingdate||1-jan-2014|
|- Target number of participants||618|
|- Interventions||1. Pooled buffy coat-derived pathogen reduced platelet concentrates (PR-plasma-PCs), or;|
2. Plasma (plasma-PCs), stored for 1-7 days.
Time of intervention has a maximum of 6 weeks.
|- Primary outcome||WHO grade ≥ 2 bleeding complications of PCs.|
|- Secondary outcome||Using PCs, stored for 1-7 days:|
1. The 1 and 24 hour CI;
2. The 1 and 24 hour CCI;
3. (1+24 hour CCI)/2;
4. Adverse transfusion reactions;
5. Total transfusion requirement of red cells and platelets;
6. Platelet transfusion interval;
7. Rate of HLA allo-immunization;
8. In vitro quality markers related with the 1-hour or 24-hour CCI;
9. Clinical factors interacting on primary endpoint, including in vivo variables of immunological responses and of hemostasis in the recipients after transfusion as compared prior to transfusion.
|- Timepoints||Prior to, and 1 hr and 24 hr after PC-transfusion.|
|- Trial web site||https://www.msbi.nl/promise/ Projects/PREPARES.aspx|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||M.D. J.L.H. Kerkhoffs|
|- CONTACT for SCIENTIFIC QUERIES||M.D. J.L.H. Kerkhoffs|
|- Sponsor/Initiator ||Sanquin Blood Bank (Stichting Sanquin Bloedvoorziening), Terumo BCT LLC|
(Source(s) of Monetary or Material Support)
|- Brief summary||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 malignancy-related myelosuppression. In this trial patients will be randomized to receive one of two platelet products during a transfusion episode with a maximum of 6 weeks. |
Because the Mirasol-treated platelet products show a color difference not allowing an appropriate placebo, the study will be single-blinded for investigators evaluating the bleeding score.
Products will be stored up to 7 days. The primary endpoint is restricted to 5 days storage as this implies the most relevant information. Secondary endpoint evaluation requires that the patient continues treatment in the assigned study arm.
Arm A: Plasma stored platelet concentrates (Plasma-PCs);
Arm B: Pathogen reduced plasma-stored platelet concentrates (PR-plasma-PCs).
|- Main changes (audit trail)||20-Jan-2013: In accordance with the METC, some changes have been accepted - NM|
1. For safety reasons, the Ethics Committee required the margin of inferiority to be reduced from 15% to 12.5%. The number of patients therefore had to be increased to 618 (from 375). To ensure timely and sufficient accrual of patients, the patient population was expanded to include all hemato oncological patients (from AML patients alone). The timeline was adjusted;
2. WHO bleeding scale is used to allow comparison with other trials in the area of platelet transfusion;
3. Due to retirement of the Principal Investigator, the responsibility of the trial was transferred to dr JL Kerkhoffs;
4. The funding source CaridianBCT merged with Terumo to form TerumoBCT.
|- RECORD||13-nov-2009 - 20-jan-2013|