| Methods |
Red Blood Cell Transfusion Thresholds and QOL in MDS (EnhanceRBC): a Pilot, Feasibility Study
Open‐label, parallel, randomised controlled trial |
| Participants |
Inclusion Criteria:
All patients with MDS ≥18 years of age Transfusion dependent: at least 1 transfusion per month in the last 8 weeks Hb < 100 g/L pre transfusion Life expectancy > 6 months
Exclusion Criteria:
Unstable cardiac disease (Canadian Cardiovascular Society (CCS) III/IV angina or New York Heart Association (NYHA) III/IV congestive heart failure) requiring the transfusion target range to remain > 85 g/L to 100 g/L at all times ECOG ≥3 Patients with red cell antibodies against high frequency antigens or multiple antibodies (would potentially delay finding blood) Patients on ESA's or disease modifying agents (like azacitidine) for their MDS
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| Interventions |
Experimental: Liberal transfusion strategy‐ maintain Hb level between 110 g/L and 120 g/L: to achieve this, 2 units of pRBCs are transfused when Hb level is < 105 g/L and 1 unit of RBCs when Hb level is 105 g/L to 110 g/L.Intervention: Other: RBC transfusions Active Comparator: Restrictive transfusion strategy‐ maintain Hb level between 85 g/L and 100 g/L: to achieve this, 2 units of pRBCs will be transfused when the Hb level is < 80 g/L and 1 unit of pRBCs when Hb level is 80 g/L to 85 g/L Intervention: Other: RBC transfusions |
| Outcomes |
Primary Outcome
Percentage compliance of fortnightly HB
The percentage compliance of fortnightly Hb being within or above the target range of the RBC transfusion threshold assigned (after the 4 week run‐in at study start as defined above). We will consider this study feasible and worthy of future development into a larger randomised trial (powered for QOL difference) if compliance is ≥70%. A compliance rate of 50% to 70%, would not exclude going forward with such an RCT but only after careful discussion and statistical planning
Secondary Outcomes
Measures of feasibility. Number of participants ineligible due to screen failure. Enrolment rates defined by the number of enrolled patients/month. Percentage compliance with QOL questionnaire completion at least 3 serial times. Other logistical issues related to protocol implementation, recruitment rates, randomisation implementation strategy, data collection, patient tolerability of study schedule Quality of life The magnitude of change in physical functioning, fatigue, dyspnoea and global health scores on the EORTC QLQ‐C30, calculated health utility on the EQ‐5D and fatigue score on FACT‐F comparing the 2 RBC transfusion thresholds above. Adverse eventsThe rate of transfusion reactions (as defined by TTISS (Transfusion Transmitted Injuries Surveillance System by Public Health Agency of Canada)). Rate of adverse events such as cardiac events and thromboembolic events as per NCI CTCAE version 4.0 criteria Alloimmunisation rates Haemosiderosis The impact on transfusion‐associated haemosiderosis rates and burdens (as measured by changes in ferritin levels and iron chelating medications) Overall utilisation of blood Time commitment The overall time commitment per group, measured as the time spent in transfusion medicine clinic
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| Notes |
Planned recruitment: 30 adults
Sponsor: Sunnybrook Health Sciences Centre
Trial registration: NCT02099669 on 26 March 2014
Location of trial: Canada
Number of study centres: 1 |
