N/A
N=62
Peri-Transfusion QOL Assessments (PTQA): A New Paradigm of Transfusion Decision Support for Patients With MDS
Myelodysplastic Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT03660228 ↗Enrolled (actual)
62
Serious AEs
—
Results posted
Jun 2024
Primary outcome: Primary: Number of Participants With Receipt of Second Transfusion
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Peri-Transfusion QOL Assessment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Receipt of Second Transfusion |
— | — |
| PRIMARY Median Difference in Units pRBCs (for Those Transfusion-dependent) |
— | — |
| PRIMARY Number of Hospitalizations (for Both Transfusion Groups) |
— | — |
| PRIMARY Number of Clinic Visits (for Both Transfusion Groups) |
— | — |
| SECONDARY PTQA Utilization |
— | — |
| SECONDARY Number of Patients With Decisional Regret |
3 | — |
| SECONDARY Perceptions of Impact of PTQA on Care |
24 | — |
| SECONDARY Perceived Stress by the Associated Scales |
— | — |
Summary
This research study is evaluating how to best tailor blood transfusion decisions to match the quality of life changes experienced by individual patients with MDS.
Eligibility Criteria
Inclusion Criteria
- Age > 18 years of age
- Patients with MDS
- Patients approaching an Hb of 8.5 g/dL during enrollment period OR
- Patients with >1 transfusion scheduled during an 8-week period
- Ability to read and understand English
Exclusion Criteria
- Age 2
- Known CHF
- Unstable Angina
- Hb level below 7.5 g/dL or above 8.5 g/dL
- No plan for future transfusion.
- Patient enrollment will happen after patient has consented and scheduled their first/next transfusion.
- Patient will not be enrolled if no future transfusions are scheduled.
Data sourced from ClinicalTrials.gov (NCT03660228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.