Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614595
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Transfusion in Lower Risk MDS Patients Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transfusion in Lower Risk MDS Patients Predictors of Adequacy of Transfusion and Quality of Life Changes
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MDS-QUAL
Brief Summary:
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
Changes in QoL will be correlated with patient cardiorespiratory function Cardiac biomarkers and plasma cytokines will also be evaluated
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 US who led its development team
Before and after rbc transfusion hemoglobin pretrasfusional hemoglobin pre and post cardiac biomarkers troponin and NTproBNP will be collectPre and post serum and plasma will also be collected for cytokine analysis
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 US who led its development team
Before and after rbc transfusion hemoglobin pretrasfusional hemoglobin pre and post cardiac biomarkers troponin and NTproBNP will be collectPre and post serum and plasma will also be collected for cytokine analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None