Transfusing these patients to a higher hemoglobin level will increase their cognition, activity and decrease the average heart rate.
ID
Bron
Verkorte titel
Aandoening
MDS, MPN
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Heart rate
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Transfusing these patients to a higher hemoglobin level will increase their cognition, activity and decrease the average heart rate.
Onderzoeksopzet
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;
Onderzoeksproduct en/of interventie
+1 or +2 RBC's at a transfusion episode, control: normal number of RBC's
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
MDS or MDS/MPN, transfusion dependent. >18 years old.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- significant cardiac, pulmonary of renal failure.
- recent change of therapy that might influence the transfusion need.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
available in our University's data warehouse but without investigator support other than deposited metadata.
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9289 |
| CCMO | NL73847.058.20 |
| OMON | NL-OMON52859 |