REDDS: study 2

  • Research type

    Research Study

  • Full title

    A Randomised Feasibility n-of-1 Trial of Weekly-Interval Red Cell Transfusion in myelodysplastic syndromes

  • IRAS ID

    265147

  • Contact name

    Andrew Charlton

  • Contact email

    Andrew.Charlton1@nhs.net

  • Sponsor organisation

    The Newcastle upon Tyne Hospital NHS Foundation Trust

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary

    Current standard of transfusion care in transfusion-dependent MDS is based on a policy for regular RBC transfusions that is typically multiple (2-4) units every 3-4 weeks. However, it is equally plausible that an alternative strategy, specifically lower dose and weekly transfusions of red cells, is more effective and acceptable, avoiding the Hb peaks, and particularly the troughs, of the current strategy.

    This two-part study will firstly compare a patient’s usual transfusion regimen against a novel weekly transfusion schedule using matched red cells, and assess a range of patient-reported QoL and functional outcomes to provide stable estimates including range and standard deviation.

    Secondly, patients and staff will also be offered the opportunity by their treating clinician to take part in a qualitative study to explore their experiences of this new weekly transfusion strategy. This will incorporate completion of semi-structured individual interviews (for patients) and focus group discussions (for staff).

  • REC name

    North East - Newcastle & North Tyneside 2 Research Ethics Committee

  • REC reference

    20/NE/0097

  • Date of REC Opinion

    20 Jul 2020

  • REC opinion

    Further Information Favourable Opinion