Transfusion Effects in Myelodysplastic Patients: Limiting Exposure

NCT ID: NCT00202371

Last Updated: 2023-11-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2005-07-31

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.

Conditions

Myelodysplastic Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Red Blood Cell transfusion

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Welfare and Sports, The Netherlands

UNKNOWN

Sponsor Role: collaborator

Sanquin Research & Blood Bank Divisions

OTHER

Sponsor Role: lead

Principal Investigators

Dick J van Rhenen, MD, PhD

Role: STUDY_DIRECTOR

Sanquin Blood Bank South West Region

Locations

Sanquin Blood Bank South West Region

Rotterdam, , Netherlands

Countries

Netherlands

References

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:CD002042. doi: 10.1002/14651858.CD002042.pub6.

Reference Type: DERIVED

PMID: 41114449 (View on PubMed)

Other Identifiers

01-021

Identifier Type: -

Identifier Source: org_study_id