Transfusion Effects in Myelodysplastic Patients: Limiting Exposure

Sanquin Research & Blood Bank Divisions

Status and phase

Withdrawn

Phase 4

Conditions

Myelodysplastic Syndromes

Treatments

Procedure: Red Blood Cell transfusion

Study type

Interventional

Funder types

Other

Identifiers

NCT00202371

01-021

Details and patient eligibility

About

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.

Full 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 physical fatigue.

Sex

All

Volunteers

Accepts Healthy Volunteers

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