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Impact of 2 Transfusion Strategies on Quality of Life of Multitransfused Patients With Low-risk Myelodysplastic Syndrome

NCT03643042 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-06-23

No results posted yet for this study

Summary

Myelodysplastic syndromes (MDS) are heterogeneous malignant bone marrow disorders characterized by ineffective haematopoiesis, peripheral blood cytopenias and variable risk of leukaemia transformation.

Anemia is the most common manifestation of bone marrow failure in MDS. After failure with first-line treatment by Erythropoietin, patients survive in average 5 years under long term blood transfusion. Modalities of blood transfusion are not clearly defined.

Then, the objective of this randomized comparative multicentric study is to compare two modalities of threshold for transfusion:

* Restrictive group: Hb \< 80g/L and Hb maintain between 80 and 100g/L
* Liberal group: Hb \< 100g/L and Hb maintain between 100 and 120g/L

Conditions

Interventions

OTHER

Transfusion

Transfusion with Hb maintain between 80 and 100g/L or Hb maintain between 100 and 120g/L

Sponsors & Collaborators

  • Lille Catholic University

    lead OTHER

Principal Investigators

  • Laurent Pascal, MD · GHICL

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-24
Primary Completion
2022-09-21
Completion
2023-03-22

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03643042 on ClinicalTrials.gov