Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS

ConditionLow Risk Myelodysplastic Syndromes

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorFundación para la Investigación Biosanitaria del Principado de Asturias

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

They must be able to understand the study procedures, comply with them, and consent in writing prior to any specific study procedure.

Must be able to understand the study procedures, comply with them, and give written informed consent prior to any study-specific procedure.

Adult subjects ≥ 18 years of age with a diagnosis of myelodysplastic syndrome.

Very low, low or intermediate IPSS-R risk category.

Disqualifiers

Subject undergoing any of the following treatments: azacitidine, decitabine, venetoclax, cytotoxic chemotherapy, radiotherapy, arsenic trioxide, interferon or interleukin.

High or very high IPSS-R risk category.

epidermoid or basal cell carcinoma,

carcinoma in situ of the uterine cervix

Trial population

Lower-risk Myelodysplastic syndrome patients, red blood cell transfusion dependent

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

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

Time frame

We expect to obtain results in one year from the beginning of the study

Secondary outcomes

Changes in QoL before and after transfusion

QoL will be assessed with QUALMS instrument, The QUALMS is being supplied by Dr. Gregory Abel at Dana-Farber in the U.S., who led its development team. He will collaborate and assist in the interpretation of the HRQoL results.

Time frame

QoL will be asses the day of transfusion and seven days after

Other outcomes

Troponin and NTproBNP as predictors for QoL improvement

To evaluate the utility of serum pretransfusional troponine and NTPROBNP as cardiac biomarkers to identify those patients whose QoL improves after the rbc transfusion

Time frame

Troponin and NTproBNP will be analyzed the day of transfusion and seven days after

Cardiorespiratory function

To evaluate the utility of oxygen consumption measured by ergospirometry to evalaute cardiorespiratory function and as a predictor of QoL improvement after rbc transfusion

Time frame

Ergospirometry will be performed at the inclusion in the study

Cytokines

To analyze changes in pro and anti-inflammatory cytokines before and after rbc transfusion

Time frame

Cytokines will be analyzed before abc transfusion and seven days after it