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…
ID
Bron
Verkorte titel
Aandoening
MDS patients
Ondersteuning
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
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Fatigue.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Red blood cell transfusion.
Publiek
Wytemaweg 10
Dick J. Rhenen, van
Wytemaweg 10,
Rotterdam 3015 CN
The Netherlands
+31 (0)10 4630630
dick.van.rhenen@bloodrtd.nl
Wetenschappelijk
Wytemaweg 10
Dick J. Rhenen, van
Wytemaweg 10,
Rotterdam 3015 CN
The Netherlands
+31 (0)10 4630630
dick.van.rhenen@bloodrtd.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL296 |
NTR-old | NTR334 |
Ander register | : N/A |
ISRCTN | ISRCTN43616311 |
Samenvatting resultaten
<br>
NVB Bulletin oktober 2002;3:2-5
<br>
Nederlands Tijdschrift voor Klinische Chemie 2003; 28: 280-284.