You are here

  • Home
  • Archive
  • Volume 6, Issue 1
  • A study protocol for a randomised controlled trial evaluating clinical effects of platelet transfusion products: the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) trial

Article Text

Article menu

Download PDFPDF

XML
Haematology (incl blood transfusion)
Protocol
A study protocol for a randomised controlled trial evaluating clinical effects of platelet transfusion products: the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) trial
  1. Paula F Ypma1,2,
  2. Pieter F van der Meer2,
  3. Nancy M Heddle3,
  4. Joost A van Hilten2,
  5. Theo Stijnen4,
  6. Rutger A Middelburg2,5,
  7. Tor Hervig6,
  8. Johanna G van der Bom2,5,
  9. Anneke Brand2,
  10. Jean-Louis H Kerkhoffs1,2
  11. for the PREPAReS Study Group
  1. 1Department of Hematology, HAGA Teaching Hospital Den Haag, The Netherlands
  2. 2Center for Clinical Transfusion Research, Sanquin Research, Leiden, The Netherlands
  3. 3Faculty of Health Sciences, Department of Medicine, Canadian Blood Services, McMaster University, and Centre for Innovation, Hamilton, Ontario, Canada
  4. 4Leiden University Medical Centre, Leiden, The Netherlands
  5. 5Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
  6. 6Department of Immunology and Transfusion Medicine, and Department of Clinical Science, Haukeland University Hospital, University of Bergen, Bergen, Norway
  1. Correspondence to Dr Paula F Ypma; p.ypma{at}sanquin.nl

Abstract

Introduction Patients with chemotherapy-induced thrombocytopaenia frequently experience minor and sometimes severe bleeding complications. Unrestrictive availability of safe and effective blood products is presumed by treating physicians as well as patients. Pathogen reduction technology potentially offers the opportunity to enhance safety by reducing bacterial and viral contamination of platelet products along with a potential reduction of alloimmunisation in patients receiving multiple platelet transfusions.

Methods and analysis To test efficacy, a randomised, single-blinded, multicentre controlled trial was designed to evaluate clinical non-inferiority of pathogen-reduced platelet concentrates treated by the Mirasol system, compared with standard plasma-stored platelet concentrates using the percentage of patients with WHO grade ≥2 bleeding complications as the primary endpoint. The upper limit of the 95% CI of the non-inferiority margin was chosen to be a ≤12.5% increase in this percentage. Bleeding symptoms are actively monitored on a daily basis. The adjudication of the bleeding grade is performed by 3 adjudicators, blinded to the platelet product randomisation as well as by an automated computer algorithm. Interim analyses evaluating bleeding complications as well as serious adverse events are performed after each batch of 60 patients. The study started in 2010 and patients will be enrolled up to a maximum of 618 patients, depending on the results of consecutive interim analyses. A flexible stopping rule was designed allowing stopping for non-inferiority or futility. Besides analysing effects of pathogen reduction on clinical efficacy, the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) is designed to answer several other pending questions and translational issues related to bleeding and alloimmunisation, formulated as secondary and tertiary endpoints.

Ethics and dissemination Ethics approval was obtained in all 3 participating countries. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

Trial registration number NTR2106; Pre-results.

  • platelet transfusion
  • pathogen reduction
  • bleeding assessment
  • bleeding
  • thrombocytopenia

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2015-010156

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text