Transfusion Effects in Myelodysplastic Patients: Limiting... | NCT00202371

Studies
Transfusion Effects in Myelodysplastic Patients: Limiting Exposure

NCT00202371

Sponsor

Sanquin Research & Blood Bank Divisions

Status

Withdrawn

Last Update Posted

Nov 24, 2023Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Myelodysplastic Syndromes

Interventions

Red Blood Cell transfusion

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Too few inclusions

Expanded Access Info

Start Date

Jul 2002

Primary Completion Date

Not provided

Completion Date

Jul 2005Estimated

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2023

Last Update Posted Date

Nov 24, 2023Actual

Name	Class
Netherlands: Ministry of Health, Welfare and Sports	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Red Blood Cell transfusion	Procedure

Measure	Description	Time Frame
fatigue

Measure	Description	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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Dick J van Rhenen, MD, PhD	Sanquin Blood Bank South West Region	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Sanquin Blood Bank South West Region		Rotterdam		3015 CH	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41114449	Derived	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.

ID	Term
D009190	Myelodysplastic Syndromes
D005221	Fatigue

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D012816	Signs and Symptoms

ID	Term
D016913	Blood Component Transfusion
D001803	Blood Transfusion
D001691	Biological Therapy
D013812	Therapeutics