Transfusion Effects in Myelodysplastic Patients: Limiting Exposure

NCT00202371 | Withdrawn Phase 4

• 1 other identifier: 01-021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndromes

Keywords

MDS, Fatigue, RBC transfusion

Outcome Measures

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

Interventions

Red Blood Cell transfusion PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sanquin Research & Blood Bank Divisions: lead
• Ministry of Health, Welfare and Sports, The Netherlands: collaborator

Study Sites (1)

Sanquin Blood Bank South West Region

Rotterdam, 3015 CH, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 41114449 DERIVED

MeSH Terms

Conditions

Myelodysplastic Syndromes; Fatigue

Interventions

Erythrocyte Transfusion

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Dick J van Rhenen, MD, PhD

  Sanquin Blood Bank South West Region

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2002
• Study Completion: July 1, 2005
• Last Updated: November 24, 2023

Record last verified: 2015-06

Locations

NL (1)