RecruitingNCT05396170
Effect of Phlebotomy on Heartrate in Polycythemia Patients
Phlebotomy in Blood Donors and Polycythemia Vera Patients- The Effect on Physiology: An Orienting Case-Cross Over Study
Sponsor
Leiden University Medical Center
Enrollment
10 participants
Start Date
Jul 21, 2022
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria6
- 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.
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Interventions
PROCEDUREphlebotomy
500ml of blood phlebotomized per standard of care to reduce symptoms from polycythemia
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05396170