Clinical trial NCT00202371: Transfusion Effects in Myelodysplastic Patients: Limiting Exposure
Official title: Transfusion Effects in Myelodysplastic Patients: Limiting Exposure (Temple)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Myelodysplastic Syndromes
Keywords: MDS, Fatigue, RBC transfusion
Lead sponsor: Sanquin Research & Blood Bank Divisions
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Welfare and Sports, The Netherlands
First posted: 2005-09-20
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 physical fatigue.

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 physical fatigue.

Eligibility criteria: 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

Primary outcomes:
measure: fatigue
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Sanquin Blood Bank South West Region
Study officials:
affiliation: Sanquin Blood Bank South West Region
name: Dick J van Rhenen, MD, PhD
role: STUDY_DIRECTOR
References: