phlebotomy: 500ml of blood phlebotomized per standard of care to reduce symptoms from polycythemia
Study summary
Single-centre, observational within-subject design: patients that undergo phlebotomies regularly for polycythemia will be measured continuously by wearables one week before until one week after a phlebotomy, for three phlebotomies.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients with polycythaemia, requiring phlebotomy on a regular basis (at least every 4 months)
* Subjects aged ≥18 years
* In possession of a smartphone
* Life expectancy ≥ 3 months
Exclusion Criteria:
* Poor performance/functional status (Eastern Cooperative Oncology Group system ECOG ≥3)
* Participants with known arrhythmias or other significant cardiological conductivity disorders (Paroxysmal atrial fibrillation is allowed)
* Hospitalized subjects
* Subjects with a pacemaker.
* Subjects with a secondary polyglobulia due to eg smoking or other pulmonary issues.
* Scheduled oncological treatments or surgery during the study period.
Primary outcome measure(s)
Mean heart rate as measured by the withings BPM and withings Steel HR biodevices — one week before until one week after phlebotomy; for three phlebotomies the Withings BPM will give point measurements while the withings Steel HR gives continuous heart rate measurements. We will compare before the phlebotomy to after phlebotomy and \>48hrs after phlebotomy, within-subjects.
Trial sites (1)
Facility
City
Region
Status
LUMC
Leiden
South Holland
Recruiting
More Leiden University Medical Center trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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