No registrations found.
ID
Source
Brief title
Health condition
MDS patients
Sponsors and support
Sanquin Blood Bank South West Region
Wytemaweg 10
3015 CN Rotterdam
The Netherlands
Tel: 0031 10-4630630
Fax: 0031 10-4630640
E-mail: dick.van.rhenen@bloodrtd.nl
Stichting Vrienden van de Bloedtransfusie
Intervention
Outcome measures
Primary outcome
Fatigue.
Secondary outcome
1. Health related Quality of Life;
2. Blood usage and the costs;
3. Haemoglobin increase after
transfusion;
4. Hart beat, blood pressure, temperature, platelet count;
5. Development of RBC alloantibodies;
6. Mortality.
Background summary
N/A
Study objective
1. There is no difference in HRQoL using a Hb transfusion trigger of 7.2 gr/dl compared to Hb transfusion trigger of 9.6 gr/dl;
2. A Hb transfusion trigger of 7.2 gr/dl leads to a diminished use of RBC transfused compared to a Hb transfusion trigger of 9.6 gr/dl;
3. A Hb transfusion trigger of 7.2 gr/dl leads to a decrease in the development of RBC allo antibodies.
Study design
N/A
Intervention
Red blood cell transfusion.
Wytemaweg 10
Dick J. Rhenen, van
Wytemaweg 10,
Rotterdam 3015 CN
The Netherlands
+31 (0)10 4630630
dick.van.rhenen@bloodrtd.nl
Wytemaweg 10
Dick J. Rhenen, van
Wytemaweg 10,
Rotterdam 3015 CN
The Netherlands
+31 (0)10 4630630
dick.van.rhenen@bloodrtd.nl
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;
3. Refractory anaemia with ringed sideroblasts (RARS): blood: ¡Ü 1% blasts, ¡Ü 1 x 109 monocytes; bone marrow: < 5% blasts, ringed sideroblasts > 15% of the erythroid cells;
4. Refractory anaemia with excess blasts (RAEB): blood: < 5% blasts, ¡Ü 1 x 109 monocytes; bone marrow: blasts ¡Ý 5 -¡Ü 20%;
5. Chronic myelomonocytic leukaemia (CMML): blood: >1 x 109/l monocytes, <5% blasts; bone marrow: blasts < 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).
Exclusion criteria
1. Candidate for bone marrow- or organ transplantation;
2. Medication: growth factors (GM-CSF), or 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): blood: ¡Ý 5% blasts or Auer rods; bone marrow: or blasts > 20 - < 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 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL296 |
| NTR-old | NTR334 |
| Other | : N/A |
| ISRCTN | ISRCTN43616311 |
Summary results
<br>
NVB Bulletin oktober 2002;3:2-5
<br>
Nederlands Tijdschrift voor Klinische Chemie 2003; 28: 280-284.