A Randomised Feasibility n-of-1 Trial of Weekly-Interval Red Cell Transfusion in myelodysplastic syndromes; Red blood cell transfusion schedule in myelodysplastic syndromes (REDDS): study 2
Recruiting
- Conditions
- malignant bone marrow diseaseMyelodysplastic syndrome10018865
- Registration Number
- NL-OMON50064
- Lead Sponsor
- Transfusion Research Unit, Monash University, Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 3
Inclusion Criteria
- Patients aged >=18 years with WHO-defined MDS or mixed
myeloproliferative/myelodysplastic neoplasm overlap syndromes (MPN/MDS)
- Transfusion dependent: at least two transfusion episodes and at least four
units of RBCs in total during the 16 weeks prior to study entry
- Continuing RBC transfusion requirement expected for at least 6 months
Exclusion Criteria
- Currently receiving RBC transfusion at an interval of <=7 days
- Unable to tolerate a weekly transfusion schedule, as determined by the
treating clinician
- Patients on erythropoietic-stimulating agent (ESA) or disease-modifying
agents for their MDS (such as lenalidomide, azacitidine, hydroxycarbamide,
experimental agents)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Feasibility of delivering a weekly transfusion schedule, as defined by a<br /><br>difference in median time between transfusions of >=7 days between the two<br /><br>treatment arms.</p><br>
- Secondary Outcome Measures
Name Time Method