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Transfusion Effects in Myelodysplastic Patients: Limiting Exposure (Temple)


Phase 4
N/A
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

Thank you

Trial Information

Transfusion Effects in Myelodysplastic Patients: Limiting Exposure (Temple)


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

fatigue

Principal Investigator

Dick J van Rhenen, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Sanquin Blood Bank South West Region

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

01-021

NCT ID:

NCT00202371

Start Date:

July 2002

Completion Date:

July 2005

Related Keywords:

  • Myelodysplastic Syndromes
  • MDS, Fatigue, RBC transfusion
  • Myelodysplastic Syndromes
  • Preleukemia

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