Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS (MDS-QUAL)

September 25, 2024 updated by: Teresa Bernal del Castillo, Fundación para la Investigación Biosanitaria del Principado de Asturias

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

At inclusion and before red blood cell (rbc) transfusion, patients cardiorespiratory function will be evaluated with an ergospirometer

Likewise, before and after rbc transfusion, patients will be asked to complete the QUALMS, a QoL instrument which will be supplied by Dr. Gregory Abel at Dana-Farber in the U.S., who led its development team.

Before and after rbc transfusion, hemoglobin, pretrasfusional hemoglobin, pre and post cardiac biomarkers troponin and NTproBNP will be collect.Pre and post serum and plasma will also be collected for cytokine analysis.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
        • Principal Investigator:
          • Teresa Bernal del CastilloBernal del Castillo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Subjects must meet all of the following inclusion criteria:

  1. They must be able to understand the study procedures, comply with them, and consent in writing prior to any specific study procedure.
  2. Must be able to understand the study procedures, comply with them, and give written informed consent prior to any study-specific procedure.
  3. Adult subjects ≥ 18 years of age with a diagnosis of myelodysplastic syndrome.
  4. Very low, low or intermediate IPSS-R risk category.
  5. Subject requires are red blood cell transfusion dependent with the following criteria: requires an average of 2 to 6 units of CH on average over an 8-week period.
  6. ECOG 0-3.

Exclusion criteria

  1. Subject undergoing any of the following treatments: azacitidine, decitabine, venetoclax, cytotoxic chemotherapy, radiotherapy, arsenic trioxide, interferon or interleukin.
  2. High or very high IPSS-R risk category.

  3. 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
  4. Subjects with a score on the New York Heart Association Scale IV.
  5. 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.
  6. 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.
  7. New onset or uncontrolled seizures.
  8. 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).
  9. Pregnant or breastfeeding women.
  10. 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.
  11. The subject has any condition or receives concomitant medication that confounds the ability to interpret the study data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of Quality of Life (QoL) improvement, assessed by an increase in 5 points or more in the QUALMs scale
Time Frame: We expect to obtain results in one year from the beginning of the study
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in QoL before and after transfusion
Time Frame: QoL will be asses the day of transfusion and seven days after
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.
QoL will be asses the day of transfusion and seven days after

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Troponin and NTproBNP as predictors for QoL improvement
Time Frame: Troponin and NTproBNP will be analyzed the day of transfusion and seven days after
To evaluate the utility of serum pretransfusional troponine and NTPROBNP as cardiac biomarkers to identify those patients whose QoL improves after the rbc transfusion
Troponin and NTproBNP will be analyzed the day of transfusion and seven days after
Cardiorespiratory function
Time Frame: Ergospirometry will be performed at the inclusion in the study
To evaluate the utility of oxygen consumption measured by ergospirometry to evalaute cardiorespiratory function and as a predictor of QoL improvement after rbc transfusion
Ergospirometry will be performed at the inclusion in the study
Cytokines
Time Frame: Cytokines will be analyzed before abc transfusion and seven days after it
To analyze changes in pro and anti-inflammatory cytokines before and after rbc transfusion
Cytokines will be analyzed before abc transfusion and seven days after it

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para la Investigación Biosanitaria del Principado de Asturias

Collaborators

Hospital Universitario Central de Asturias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2024

Primary Completion (Estimated)

December 20, 2025

Study Completion (Estimated)

December 21, 2025

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024.244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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