Clinical trial NCT05396170: Effect of Phlebotomy on Heartrate in Polycythemia Patients
Official title: Phlebotomy in Blood Donors and Polycythemia Vera Patients- The Effect on Physiology: An Orienting Case-Cross Over Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polycythemia
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with polycythaemia, requiring phlebotomy on a regular basis (at least every 4 months)

Brief 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.

Detailed description: Rationale: Little is known about the effect of a hemoglobin-shift on patients, anaemic, non-anaemic or even polycythaemic. It has been established that severe anaemia has deteriorating effects on the patient, which can be (partially) reversed by treatments like transfusion, erythropoietin stimulating agents or iron/vitamin supplements, depending of the etiology of the anaemia. However, the optimal haemoglobin target and threshold for such treatments has yet to be determined. It is therefore necessary to evaluate what the exact effect of various haemoglobin levels, and a shift therein, is on the physiology of patients. Only then can the benefits be weighed properly against the risks for individual patients when considering treatment for anaemia, safety of blood donation, or expected effect of phlebotomy for polycythaemia.

Primary Objective:

- Compare the per individual and per group effects of a reduction in Hb mass on physical functional outcomes (heart rate; activity parameters; QoL) in patients with polycythaemia.

Secondary Objectives:

- Compare the primary outcomes to data from the REMOTE-2 and FAINT-study (similar measurements in transfusion dependent patients and whole blood donors)

Study design: Within-subject design. Patients will be remotely monitored one week before phlebotomy until one week after.

Study population: Adult patients with a polycythaemia requiring phlebotomies on a regular basis.

Main study parameters: heart rate, blood pressure, activity parameters and quality of life.

Eligibility criteria: 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 outcomes:
measure: Mean heart rate as measured by the withings BPM and withings Steel HR biodevices
timeFrame: one week before until one week after phlebotomy; for three phlebotomies
Secondary outcomes:
measure: Systolic and diastolic blood pressure as measured by the withings BPM connect.
timeFrame: Daily basis from one week before until one week after phlebotomy; three phlebotomies
measure: Number of steps per 24hrs as measured by the withings steel HR
timeFrame: one week before until one week after phlebotomy; for three phlebotomies
measure: Quality of life as measured by the EuroQol-5D questionnaire (EQ5D)
timeFrame: Daily basis from one week before until one week after phlebotomy; three phlebotomies
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: LUMC
state: Zuid-Holland
Study officials:
affiliation: LUMC
name: Jaap Jan Zwaginga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: