Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS
Recruiting now
Conditions studied: Low Risk Myelodysplastic Syndromes
In brief
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.
Key facts
- Study ID
- NCT06614595
- Run by
- Fundación para la Investigación Biosanitaria del Principado de Asturias
- People needed
- 30
- Starts
- 2024-09-20
- Expected to finish
- 2025-12-21
- Last updated by the study team
- 2024-09-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
- Subject diagnosed with any active neoplasm except:
- epidermoid or basal cell carcinoma,
- carcinoma in situ of the uterine cervix
- Carcinoma in situ of the breast
- Subjects with a score on the New York Heart Association Scale IV.
- Subjects with major surgery within 8 weeks prior to study inclusion. Subjects must have fully recovered from any previous surgery prior to inclusion in the study.
- Subject with known clinically significant anaemia due to iron, vitamin B12 or folate deficiencies or autoimmune or hereditary haemolytic anaemia or uncontrolled hypothyroidism or known clinically significant haemorrhage or sequestration or subject with drug induced anaemia.
- New onset or uncontrolled seizures.
- Subjects with uncontrolled systemic fungal, bacterial or viral infections (defined as ongoing signs or symptoms related to the infection without improvement despite appropriate antibiotics or antimicrobial therapy).
- Pregnant or breastfeeding women.
- The subject has any condition, including the presence of laboratory abnormalities that would place the subject at unacceptable risk if he/she were to participate in the study.
- The subject has any condition or receives concomitant medication that confounds the ability to interpret the study data.
Where it is running
- Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain (enrolling)
Full record on ClinicalTrials.gov
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