Status:
WITHDRAWN
Transfusion Effects in Myelodysplastic Patients: Limiting Exposure
Lead Sponsor:
Sanquin Research & Blood Bank Divisions
Collaborating Sponsors:
Ministry of Health, Welfare and Sports, The Netherlands
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The goal of this study was to compare a restrictive RBC transfusion policy (a Hb transfusion trigger: 7.2 gr/dl) with a more liberal RBC transfusion policy (a Hb transfusion trigger: 9.6 gr/dl) on phy...
Detailed Description
The goal of this study was to compare a restrictive RBC transfusion policy (a Hb transfusion trigger of 7.2 gr/dl) with a more liberal RBC transfusion policy (a Hb transfusion trigger of 9.6 gr/dl) on...
Eligibility Criteria
Inclusion
- 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.
- refractory anaemia (RA): blood: ≤ 1% blasts, ≤ 1 x 109 monocytes; bone marrow: \< 5% blasts, ringed sideroblasts ≤ 15% of the erythroid cells
- refractory anaemia with ringed sideroblasts (RARS): blood: ≤ 1% blasts, ≤ 1 x 109 monocytes; bone marrow: \< 5% blasts, ringed sideroblasts \> 15% of the erythroid cells
- refractory anaemia with excess blasts (RAEB): blood: \< 5% blasts, ≤ 1 x 109 monocytes; bone marrow: blasts ≥ 5 -≤ 20%
- chronic myelomonocytic leukaemia (CMML): blood: \>1 x 109/l monocytes, \<5% blasts; bone marrow: blasts \< 20%, increase of the monocytic component
- erythrocyte transfusion need
- working knowledge of the national language
- written consent for participating this study (informed consent)
Exclusion
- candidate for bone marrow- or organ transplantation
- medication: growth factors (GM-CSF), or EPO
- patients who will receive an intensive chemotherapeutic treatment with a cytopenia, expected longer than 2 weeks
- refractory anaemia with excess blasts in transformation (RAEB-t): blood: ≥ 5% blasts or Auer rods; bone marrow: or blasts \> 20 - \< 30% or Auer rods
- pregnancy at the moment of inclusion
- patients with congenital severe haemolytic anaemia, like thalassemia or sickle cell anaemia
- patients with AIDS or a severe congenital or acquired (e.g. iatrogenic) immunological disorder
- severe active infections at the moment of inclusion
- severe cardiac, pulmonal, neurological, metabolic or psychiatric disease at the moment of inclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00202371
Start Date
July 1 2002
End Date
July 1 2005
Last Update
November 24 2023
Active Locations (1)
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1
Sanquin Blood Bank South West Region
Rotterdam, Netherlands, 3015 CH