Topic: Cancer
Conditions
Interventions
Transfusion Strategy, Eligible, informed and consented patients will be randomised to one of two red cell transfusion strategies:
1. Restrictive transfusion strategy to maintain haemog
where 2 units of packed red cell unit transfusions are transfused when the haemoglobin concentration level is < 80g/L and 1 unit of packed red cell unit transfusions when haemoglobin concentration lev
Study Entry : Single Randomisation only
Sponsors
NHS Blood and Transplant (NHSBT)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All patients with MDS =18 years of age and with 6 months
Exclusion criteria
Exclusion criteria: 1 .Unable, in the opinion of the attending clinician, to tolerate restrictive or liberal red cell transfusion thresholds (e.g. clinically significant cardio-respiratory compromise) 2. Poor performance/functional status (Eastern Cooperative Oncology Group system ECOG =3) 3. Patients being actively treated with erythropiesis stimulating agents (ESAs) or disease modifying agents for their MDS (such as lenalidomide, azacitidine, hydroxycarbamide, experimental agents), as these may exert their own effects on the patients' quality of life and may render patients transfusion independent 4. Patients with myelofibrosis 5. Patients in whom the attending clinician considers that active bleeding or ongoing haemolysis contribute significantly to the cause of anaemia 6. Patients presenting with splenomegaly >5cm below the costal margin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes of this feasibility study, from day 0 to day 84, will be: 1. The percentage compliance of pre-transfusion haemoglobin concentrations being within or above the target range of the red cell transfusion threshold assigned 2. Achievement of at least a 20 g/L difference between the mean pre-transfusion haemoglobins in the liberal and restrictive strategy groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of patients ineligible due to screening failure or workload of department 2. Enrolment rates defined as number of patients enrolled per month, number of replaced patients and patient tolerability of study schedule 3. Percentage compliance with completing the QoL questionnaires at scheduled study visits 4. Ability of patients to remain blinded to the treatment arm 5. Proportion of transfusions and proportion of patients with all transfusions given correctly, according to the algorithm 6. Percentage of pre-transfusion haemoglobin concentrations falling below, within and above the target range of the red cell transfusion threshold assigned 7. The magnitude of change in physical functioning, fatigue, dyspnoea and global health scores on the EORTC QLQ-C30 and calculated health utility on the EQ-5D comparing the two RBC transfusion thresholds, with clinically significant differences of 10 points for the QLQ-C30 and 0.08 points for the EQ-5D 8. Numbers of adverse events such as cardiac events and thromboembolic events, and transfusion reactions (as defined and adapted from SHOT definitions and as applied in other NHSBT CTU trials), per arm 9. The overall utilisation of blood during study period per group, to evaluate the amount of extra red cell units transfused/week/patient associated with the liberal strategy | — |
Countries
United Kingdom
Outcome results
None listed