Red cell transfusion and QoL in myelodysplastic syndromes

Not Applicable

Completed

• Conditions: Topic: Cancer; Subtopic: Haematological Oncology; Disease: Myelodysplastic syndromes; Cancer

• Registration Number: ISRCTN26088319
• Lead Sponsor: HS Blood and Transplant (NHSBT)

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/31960409/ (added 26/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-13
• Study Completion: 2018-10-30
• Last Update Posted: 8 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. All patients with MDS =18 years of age and with < 20% blasts on bone marrow aspirate (WHO classification), including non-proliferative CMML and other MDS/MPN overlap diseases. These patients will include both those recently diagnosed and with an established diagnosis
2. Transfusion dependent: at least 1 red cell transfusion episode per month in the last 8 weeks
3. Life expectancy >6 months

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The primary outcomes of this feasibility study, from day 0 to day 84, will be:<br> 1. The percentage compliance of pre-transfusion haemoglobin concentrations being within or above the target range of the red cell transfusion threshold assigned<br> 2. Achievement of at least a 20 g/L difference between the mean pre-transfusion haemoglobins in the liberal and restrictive strategy groups<br>