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Transfusion Effects in Myelodysplastic Patients: Limiting Exposure

Primary Purpose

Myelodysplastic Syndromes

Status
Withdrawn
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Red Blood Cell transfusion
Sponsored by
Sanquin Research & Blood Bank Divisions
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring MDS, Fatigue, RBC transfusion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sanquin Blood Bank South West Region

Outcomes

Primary Outcome Measures

fatigue

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
June 1, 2015
Sponsor
Sanquin Research & Blood Bank Divisions
Collaborators
Netherlands: Ministry of Health, Welfare and Sports
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1. Study Identification

Unique Protocol Identification Number
NCT00202371
Brief Title
Transfusion Effects in Myelodysplastic Patients: Limiting Exposure
Official Title
Transfusion Effects in Myelodysplastic Patients: Limiting Exposure (Temple)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Too few inclusions
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sanquin Research & Blood Bank Divisions
Collaborators
Netherlands: Ministry of Health, Welfare and Sports

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
MDS, Fatigue, RBC transfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Red Blood Cell transfusion
Primary Outcome Measure Information:
Title
fatigue
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dick J van Rhenen, MD, PhD
Organizational Affiliation
Sanquin Blood Bank South West Region
Official's Role
Study Director
Facility Information:
Facility Name
Sanquin Blood Bank South West Region
City
Rotterdam
ZIP/Postal Code
3015 CH
Country
Netherlands

12. IPD Sharing Statement

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Transfusion Effects in Myelodysplastic Patients: Limiting Exposure

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