Effect of Phlebotomy on Heartrate in Polycythemia Patients
ConditionPolycythemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLeiden University Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Patients with polycythaemia, requiring phlebotomy on a regular basis (at least every 4 months)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
phlebotomy
Procedure/Surgery500ml of blood phlebotomized per standard of care to reduce symptoms from polycythemia
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Mean heart rate as measured by the withings BPM and withings Steel HR biodevices
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.
Time frame
one week before until one week after phlebotomy; for three phlebotomiesSecondary outcomes
1
Systolic and diastolic blood pressure as measured by the withings BPM connect.
BP (systolic/diastolic) measured by Withings BPM connect
Time frame
Daily basis from one week before until one week after phlebotomy; three phlebotomies2
Number of steps per 24hrs as measured by the withings steel HR
Steps as a measure for activity as measured by the withings steel HR
Time frame
one week before until one week after phlebotomy; for three phlebotomies3
Quality of life as measured by the EuroQol-5D questionnaire (EQ5D)
QoL as measured by the castor-based EQ5D. The EQ5D gives two scores: the utility score (range: -.329 to 1, higher is better, lower than 0 is considered worse than death) and an VAS (visual analogue scale) score (range 0 to 100, higher is better)
Time frame
Daily basis from one week before until one week after phlebotomy; three phlebotomiesSponsors and contacts
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Source ClinicalTrials.gov