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ID
Source
Brief title
Health condition
MDS, MPN
Sponsors and support
Intervention
Outcome measures
Primary outcome
Heart rate
Secondary outcome
Cognition, activity, QoL
Background summary
24 transfusion dependent MDS/MPN patients receive 3 different amounts of RBC transfusion (Standard of Care(SoC) amount, SoC+1 and SoC+2). Continuous heart rates and activity parameters are monitored using a smartwatch, cognitive and QoL parameters are measured with web-based tests/questionnaires.
Study objective
Transfusing these patients to a higher hemoglobin level will increase their cognition, activity and decrease the average heart rate.
Study design
0) Baseline demographics
Continuously(during each study transfusion cycle): heart rate and activity parameters with withings steel HR smartwatch
First study transfusion
1) 1-3 days before study transfusion: QUALMS and MFI questionnaires; CANTAB Cognitive tasks: RVP SWM and OTS; Heart rate and bloodpressure with Withings BPM connect; Hemoglobin level.
2) directly after study transfusion: Hemoglobin level
3) 2-4 days after study transfusion: QUALMS and MFI questionnaires; CANTAB Cognitive tasks: RVP SWM and OTS; Heart rate and bloodpressure with Withings BPM connect;
4) 1-3 days before next transfusion: QUALMS and MFI questionnaires + questionnaire on experience of last transfusion; CANTAB Cognitive tasks: RVP SWM and OTS; Heart rate and bloodpressure with Withings BPM connect;
Second study transfusion
5) 1-3 days before study transfusion: QUALMS and MFI questionnaires; CANTAB Cognitive tasks: RVP SWM and OTS; Heart rate and bloodpressure with Withings BPM connect; Hemoglobin level.
6) directly after study transfusion: Hemoglobin level
7) 2-4 days after study transfusion: QUALMS and MFI questionnaires; CANTAB Cognitive tasks: RVP SWM and OTS; Heart rate and bloodpressure with Withings BPM connect;
8) 1-3 days before next transfusion: QUALMS and MFI questionnaires+ questionnaire on experience of last transfusion; CANTAB Cognitive tasks: RVP SWM and OTS; Heart rate and bloodpressure with Withings BPM connect;
third study transfusion
9) 1-3 days before study transfusion: QUALMS and MFI questionnaires; CANTAB Cognitive tasks: RVP SWM and OTS; Heart rate and bloodpressure with Withings BPM connect; Hemoglobin level.
10) directly after study transfusion: Hemoglobin level
11) 2-4 days after study transfusion: QUALMS and MFI questionnaires; CANTAB Cognitive tasks: RVP SWM and OTS; Heart rate and bloodpressure with Withings BPM connect;
12) 1-3 days before next transfusion: QUALMS and MFI questionnaires+ questionnaire on experience of last transfusion; CANTAB Cognitive tasks: RVP SWM and OTS; Heart rate and bloodpressure with Withings BPM connect;
Intervention
+1 or +2 RBC's at a transfusion episode, control: normal number of RBC's
Inclusion criteria
MDS or MDS/MPN, transfusion dependent. >18 years old.
Exclusion criteria
- significant cardiac, pulmonary of renal failure.
- recent change of therapy that might influence the transfusion need.
Design
Recruitment
IPD sharing statement
Plan description
available in our University's data warehouse but without investigator support other than deposited metadata.
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9289 |
| CCMO | NL73847.058.20 |
| OMON | NL-OMON52859 |