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WithdrawnNCT00202371Updated Nov 24, 2023

Transfusion Effects in Myelodysplastic Patients: Limiting Exposure

A Phase 4 interventional study of Red Blood Cell transfusion in Myelodysplastic Syndromes, sponsored by Sanquin Research & Blood Bank Divisions. Withdrawn at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2023-11-24.

Sponsored by Sanquin Research & Blood Bank Divisions · Phase 4, Interventional, and Treatment

Why this study was withdrawn
Too few inclusions
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Myelodysplastic Syndromes

Keywords

  • MDS, Fatigue, RBC transfusion
03

In context

Myelodysplastic Syndromes

2,165 studies on the registry are indexed under Myelodysplastic Syndromes; 322 are open to participants now.

Browse Myelodysplastic Syndromes studies →

Lead sponsor

Sanquin Research & Blood Bank Divisions is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
0 participants (actual)

Interventions

  • ProcedureRed Blood Cell transfusion
06

What researchers measure

Primary outcomes

  1. fatigue

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Sanquin Blood Bank South West Region
    Rotterdam, 3015 CH, Netherlands
08

References and documents

Publications

  • Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6. PubMed 41114449 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00202371
Lead sponsor
Sanquin Research & Blood Bank Divisions
Collaborators
Netherlands: Ministry of Health, Welfare and Sports
First posted
Sep 20, 2005
Start date
Jul 2002
Completion
Jul 2005 (estimated)
Last update
Nov 24, 2023

Study contacts

Dick J van Rhenen, MD, PhD
study director · Sanquin Blood Bank South West Region

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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