Transfusion Effects in Myelodysplastic Patients: Limiting Exposure

Transfusion Effects in Myelodysplastic Patients: Limiting Exposure (Temple)

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00202371

Enrollment

Registered

2005-09-20

Start date

2002-07-31

Completion date

2005-07-31

Last updated

2023-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndromes

Keywords

MDS, Fatigue, RBC transfusion

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.

Interventions

PROCEDURERed Blood Cell transfusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
fatigue	—

Secondary

Measure	Time frame
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	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026