Effect of Phlebotomy on Heartrate in Polycythemia Patients (NOSFERATU)

Leiden University Medical Center (LUMC)

Status: Enrolling

Conditions: Polycythemia

Treatments: Procedure: phlebotomy

Study type: Observational

Funder types: Other

Identifiers

NCT05396170

N22.055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design