Effect of Phlebotomy on Heartrate in Polycythemia Patients

Recruiting

• Conditions: Polycythemia

• Registration Number: NCT05396170
• Lead Sponsor: Leiden University Medical Center

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.

Study Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-31
• Study Start: 2022-07-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Number of steps per 24hrs as measured by the withings steel HR	one week before until one week after phlebotomy; for three phlebotomies	Steps as a measure for activity as measured by the withings steel HR
Systolic and diastolic blood pressure as measured by the withings BPM connect.	Daily basis from one week before until one week after phlebotomy; three phlebotomies	BP (systolic/diastolic) measured by Withings BPM connect
Quality of life as measured by the EuroQol-5D questionnaire (EQ5D)	Daily basis from one week before until one week after phlebotomy; three phlebotomies	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)

Trial Locations

Locations (1)

LUMC; 🇳🇱 Leiden, Zuid-Holland, Netherlands