Transfusion Effects in Myelodysplastic Patients: Limiting Exposure

Study Overview
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Brief Summary
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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 physical fatigue.

Detailed Description
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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 physical fatigue.

Official Title
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Transfusion Effects in Myelodysplastic Patients: Limiting Exposure (Temple)

Conditions
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Myelodysplastic Syndromes

Intervention / Treatment
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* Procedure: Red Blood Cell transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Red Blood Cell transfusion|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatigue |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related Quality of Life, Blood usage and the costs, Haemoglobin increase after transfusion, Heart beat, blood pressure, temperature, platelet count, Development of RBC alloantibodies, Mortality |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDS, Fatigue, RBC transfusion