Temple study.
Completed
- Conditions
- MDS patients
- Registration Number
- NL-OMON24147
- Lead Sponsor
- Sanquin Blood Bank South West RegionSanquin Blood Bank South West RegionWytemaweg 103015 CN RotterdamThe NetherlandsTel: 0031 10-4630630Fax: 0031 10-4630640E-mail: dick.van.rhenen@bloodrtd.nl
- Brief Summary
British Journal of Haematology 2003;121(2):270-274 <br> NVB Bulletin oktober 2002;3:2-5 <br> Nederlands Tijdschrift voor Klinische Chemie 2003; 28: 280-284.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Diagnosis myelodysplastic syndrome (primary or secondary) based on cytopenia in at least 1 cell line + dysplasia in 2 cell lines (and no other cause (especially deficiencies)) and a pathologic anatomic diagnosis after bone marrow punction;
2. Refractory anaemia (RA): blood: ¡Ü 1% blasts, ¡Ü 1 x 109 monocytes; bone marrow: < 5% blasts, ringed sideroblasts ¡Ü 15% of the erythroid cells;
Exclusion Criteria
1. Candidate for bone marrow- or organ transplantation;
2. Medication: growth factors (GM-CSF), or EPO;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fatigue.
- Secondary Outcome Measures
Name Time Method 1. Health related Quality of Life;<br /><br>2. Blood usage and the costs;<br /><br>3. Haemoglobin increase after <br>transfusion;<br /><br>4. Hart beat, blood pressure, temperature, platelet count;<br /><br>5. Development of RBC alloantibodies;<br /><br>6. Mortality.