NCT06614595|Unknown
Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS
MDS-QUAL
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MDS-QUAL
Sponsor study identifier
observational
30
1 country
1
Study Start
September 20, 2024
Actual (reported)Primary Completion
December 20, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 21, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Observational study to evaluate changes in quality of life (QoL) in patients diagnosed with low risk MDS who are red blood cell (abc) transfusion dependent. Changes in QoL will be correlated with patient cardiorespiratory function. Cardiac biomarkers and plasma cytokines will also be evaluated.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 21, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 20, 2024
Actual (reported)September 24, 2024
Actual (reported)September 26, 2024
Actual (reported)December 20, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 21, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Prediction of Quality of Life (QoL) improvement, assessed by an increase in 5 points or more in the QUALMs scale
To design a score that help to identify which patients benefit from red blood cell Transfusion in terms of QoL improvement
We expect to obtain results in one year from the beginning of the study
Changes in QoL before and after transfusion
QoL will be asses the day of transfusion and seven days after
Troponin and NTproBNP as predictors for QoL improvement
Troponin and NTproBNP will be analyzed the day of transfusion and seven days after
Cardiorespiratory function
Ergospirometry will be performed at the inclusion in the study
Cytokines
Cytokines will be analyzed before abc transfusion and seven days after it
Lower-risk Myelodysplastic syndrome patients, red blood cell transfusion dependent
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Abel GA, Efficace F, Buckstein RJ, Tinsley S, Jurcic JG, Martins Y, Steensma DP, Watts CD, Raza A, Lee SJ, List AF, Klaassen RJ. Prospective international validation of the Quality of Life in Myelodysplasia Scale (QUALMS). Haematologica. 2016 Jun;101(6):781-8. doi: 10.3324/haematol.2015.140335. Epub 2016 Mar 4.
Abel GA, Klepin HD, Magnavita ES, Jaung T, Lu W, Shallis RM, Hantel A, Bahl NE, Dellinger-Johnson R, Winer ES, Zeidan AM. Peri-transfusion quality-of-life assessment for patients with myelodysplastic syndromes. Transfusion. 2021 Oct;61(10):2830-2836. doi: 10.1111/trf.16584. Epub 2021 Jul 12.
serum and plasma for cytokine analysis
First Submitted
September 24, 2024
First Posted
September 26, 2024
Study Start
September 20, 2024
Actual (reported)Primary Completion
December 20, 2025
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 21, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 27, 2024
Record last verified: 2024-09
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