Transfusion Effects of Myelodysplastic Patients: Limiting Exposure
- Conditions
- Myelodysplastic Syndrome (MDS)CancerMyelodysplastic Syndrome
- Registration Number
- ISRCTN43616311
- Lead Sponsor
- Sanquin Blood Bank South West Region (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
1. Diagnosis myelodysplastic syndrome (primary or secondary) based on cytopenia in at least 1 cell line and dysplasia in 2 cell lines (and no other cause [especially deficiencies]) and a pathologic anatomic diagnosis after bone marrow punction
2. Refractory Anaemia (RA):
2.1. Blood: less than or equal to 1% blasts, less than or equal to 1 x 10^9 monocytes
2.2. Bone marrow: less than 5% blasts, ringed sideroblasts less than or equal to 15% of the erythroid cells
3. Refractory Anaemia with Ringed Sideroblasts (RARS):
3.1. Blood: less than or equal to 1% blasts, less than or equal to 1 x 10^9 monocytes
3.2. Bone marrow: less than 5% blasts, ringed sideroblasts greater than 15% of the erythroid cells
4. Refractory Anaemia with Excess Blasts (RAEB):
4.1. Blood: less than 5% blasts, less than or equal to 1 x 10^9 monocytes
4.2. Bone marrow: blasts greater than or equal to 5% to less than or equal to 20%
5. Chronic Myelomonocytic Leukaemia (CMML):
5.1. Blood: greater than 1 x 10^9/l monocytes, less than 5% blasts
5.2. Bone marrow: blasts less than 20%, increase of the monocytic component
6. Erythrocyte transfusion need
7. Working knowledge of the national language
8. Written consent for participating this study (informed consent)
1. Candidate for bone marrow or organ transplantation
2. Medication: growth factors (Granulocyte Monocyte Colony Stimulating Factor [GM-CSF]), or Erythropoietin (EPO)
3. Patients who will receive an intensive chemotherapeutic treatment with a cytopenia, expected longer than 2 weeks
4. Refractory anaemia with excess blasts in transformation (RAEB-t):
4.1. Blood: 5% blasts or Auer rods
4.2. Bone marrow: or blasts greater than 20% to less than 30% or Auer rods
5. Pregnancy at the moment of inclusion
6. Patients with congenital severe haemolytic anaemia, like thalassemia or sickle cell anaemia
7. Patients with Acquired Immune Deficiency Syndrome (AIDS) or a severe congenital or acquired (e.g., iatrogenic) immunological disorder
8. Severe active infections at the moment of inclusion
9. Severe cardiac, pulmonal, neurological, metabolic or psychiatric disease at the moment of inclusion
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 (HRQoL)<br>2. Blood usage and the costs<br>3. Haemoglobin increase after transfusion<br>4. Heart beat, blood pressure, temperature, platelet count<br>5. Development of RBC alloantibodies<br>6. Mortality