NCT03643042

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

Impact of 2 Transfusion Strategies on the Quality of Life of Multi-transfused Patients With Low Risk Myelodysplastic Syndrome: Multicenter Randomized Trial Comparing a Liberal vs. Restrictive Transfusion Regimen

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Lille Catholic University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Myelodysplastic syndromes (MDS) are heterogeneous malignant bone marrow disorders characterized by ineffective haematopoiesis, peripheral blood cytopenias and variable risk of leukaemia transformation. The median age at diagnosis is 75 years. The incidence is about 30 per 100,000, over 70 years. Etiology is unknown in more than 85% of cases, chemo-induced causes and family cases are well individualized. Diagnosis, prognosis, and classification (WHO) are based on joint cytologic analysis of peripheral blood, bone marrow, and spinal cytogenetic analysis. The main therapeutic objectives in low-risk MDS are to correct cytopenias, improve quality of life and prevent aggravation of co-morbidities. Anemia is the most common manifestation of bone marrow failure in MDS. It is encountered in 80% of cases at diagnosis and almost always occurs in the progression of the disease. Its presence and importance have a pejorative prognostic value, but it is not clear whether this anemia is indicative of a more serious clonal disease or whether it is the repercussions of anemia that lead to a more severe prognosis. After failure with first-line treatment by Erythropoietin (EPO), patients survive in average 5 years under long term blood transfusion. Modalities of blood transfusion are not clearly defined. Studies in the general geriatric population and in cases of acute anemia are in favor of a restrictive transfusion regimen (threshold around 70 g/L), while experience during MDS with EPO suggest that maintaining a higher hemoglobin count could have a favorable impact on quality of life, physical performance, or even survival of patients with MDS. 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

• Myelodysplastic Syndromes
• Transfusion-dependent Anemia

Interventions

Type	Name	Description
OTHER	Transfusion	Transfusion with Hb maintain between 80 and 100g/L or Hb maintain between 100 and 120g/L

Timeline

• Start date: 2021-03-24
• Primary completion: 2022-09-21
• Completion: 2023-03-22
• First posted: 2018-08-22
• Last updated: 2023-06-23

Locations

19 sites across 1 country: France