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Clinical Trials/NCT00202371
NCT00202371WithdrawnPhase 4

Transfusion Effects in Myelodysplastic Patients: Limiting Exposure (Temple)

Sanquin Research & Blood Bank Divisions2 sites in 1 countryStarted: July 1, 2002Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Withdrawn
Sponsor
Locations
2
Primary Endpoint
fatigue
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

fatigue

Secondary Outcomes

  • 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

Investigators

Sponsor
Sanquin Research & Blood Bank Divisions
Sponsor Class
Other

Study Sites (2)

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