Transfusion Effects in Myelodysplastic Patients: Limiting Exposure

Phase 4

Withdrawn

• Conditions: Myelodysplastic Syndromes

• Registration Number: NCT00202371
• Lead Sponsor: Sanquin Research & Blood Bank Divisions

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 Timeline

• Study Start: 2002-07
• Study Completion: 2005-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Status Verified: 2015-06
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
fatigue

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanquin Blood Bank South West Region; 🇳🇱 Rotterdam, Netherlands