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Temple study.


- candidate number1532
- NTR NumberNTR334
- ISRCTNISRCTN43616311
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR10-sep-2005
- Secondary IDsN/A 
- Public TitleTemple study.
- Scientific TitleTransfusion Effects of Myelodysplastic Patients: Limiting Exposure.
- ACRONYMTemple study
- hypothesis1. 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.
- Healt Condition(s) or Problem(s) studiedMyelodysplastic syndrome (MDS)
- Inclusion criteria1. 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: 1% blasts, 1 x 109 monocytes; bone marrow: < 5% blasts, ringed sideroblasts 15% of the erythroid cells;
3. Refractory anaemia with ringed sideroblasts (RARS): blood: 1% blasts, 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, 1 x 109 monocytes; bone marrow: blasts 5 - 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 criteria1. 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: 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-feb-2002
- planned closingdate31-dec-2006
- Target number of participants200
- InterventionsRed blood cell transfusion.
- Primary outcomeFatigue.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. PhD. Dick J. Rhenen, van
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Dick J. Rhenen, van
- Sponsor/Initiator Sanquin Blood Bank South West Region
- Funding
(Source(s) of Monetary or Material Support)
Dutch Ministry of Health, Welfare and Sport, National Institute of Public Health and Environmental Protection (RIVM), Stichting Vrienden van de Bloedtransfusie
- PublicationsBritish Journal of Haematology 2003;121(2):270-274
NVB Bulletin oktober 2002;3:2-5
Nederlands Tijdschrift voor Klinische Chemie 2003; 28: 280-284.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD10-sep-2005 - 14-sep-2009


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