Effect of Phlebotomy on Heartrate in Polycythemia Patients

NCT ID: NCT05396170

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-21
• Study Completion Date: 2025-01-01

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.

Conditions

Polycythemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

phlebotomy

500ml of blood phlebotomized per standard of care to reduce symptoms from polycythemia

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

jjzwaginga

Prof. dr. J.J. Zwaginga

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaap Jan Zwaginga, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

LUMC

Locations

LUMC

Leiden, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Rik Tonino, MD

Role: CONTACT

r.p.b.tonino@lumc.nl

+31623248432

Jaap Jan Zwaginga, MD, PhD

Role: CONTACT

j.j.zwaginga@lumc.nl

071 526 9111 ext. +31

Facility Contacts

Rik Tonino, MD

Role: primary

r.p.b.tonino@lumc.nl

Jaap Jan Zwaginga, MD, PhD

Role: backup

J.J.zwaginga@lumc.nl

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

N22.055

Identifier Type: -

Identifier Source: org_study_id