Actively Recruiting
Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS
Led by Fundación para la Investigación Biosanitaria del Principado de Asturias · Updated on 2024-09-27
30
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
F
Fundación para la Investigación Biosanitaria del Principado de Asturias
Lead Sponsor
H
Hospital Universitario Central de Asturias
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and comply with study procedures and provide written consent
- Adults aged 18 years or older with a diagnosis of myelodysplastic syndrome
- Classified as very low, low, or intermediate risk by IPSS-R
- Dependent on red blood cell transfusions, averaging 2 to 6 units over 8 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 3
You will not qualify if you...
- Receiving treatments such as azacitidine, decitabine, venetoclax, cytotoxic chemotherapy, radiotherapy, arsenic trioxide, interferon, or interleukin
- Classified as high or very high risk by IPSS-R
- Diagnosed with active cancers except certain skin or cervical/breast carcinomas in situ
- New York Heart Association Scale IV heart failure
- Major surgery within 8 weeks prior to study entry without full recovery
- Clinically significant anemia due to iron, vitamin B12, folate deficiencies, autoimmune or hereditary hemolytic anemia, uncontrolled hypothyroidism, significant hemorrhage, sequestration, or drug-induced anemia
- New onset or uncontrolled seizures
- Uncontrolled systemic fungal, bacterial, or viral infections despite treatment
- Pregnant or breastfeeding women
- Any condition or lab abnormality posing unacceptable risk for study participation
- Conditions or medications that interfere with interpreting study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
Research Team
T
Teresa Bernal del Castillo
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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