Transfusion Effects in Myelodysplastic Patients: Limiting Exposure

Myelodysplastic Syndromes Clinical Trial

Official title:

Transfusion Effects in Myelodysplastic Patients: Limiting Exposure (Temple)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00202371
• Other study ID #: 01-021
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 2002
• Est. completion date: July 2005

Study information

• Verified date: June 2015
• Source: Sanquin Research & Blood Bank Divisions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Myelodysplastic Syndromes

Intervention

Procedure:
• Red Blood Cell transfusion

Locations

Country	Name	City	State
Netherlands	Sanquin Blood Bank South West Region	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Sanquin Research & Blood Bank Divisions	Ministry of Health, Welfare and Sports, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue
Secondary	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