Effect of Phlebotomy on Heartrate in Polycythemia Patients (NOSFERATU)

Phlebotomy in Blood Donors and Polycythemia Vera Patients- The Effect on Physiology: An Orienting Case-Cross Over Study

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.

Study Overview

• Status: Recruiting
• Conditions: Polycythemia
• Intervention / Treatment: Procedure: phlebotomy

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 Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Rik Tonino, MD; Phone Number: +31623248432; Email: r.p.b.tonino@lumc.nl
• Study Contact Backup: Name: Jaap Jan Zwaginga, MD, PhD; Phone Number: +31 071 526 9111; Email: j.j.zwaginga@lumc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands
      • Recruiting
      • LUMC
      • Contact: Rik Tonino, MD; Email: r.p.b.tonino@lumc.nl
      • Contact: Jaap Jan Zwaginga, MD, PhD; Email: J.J.zwaginga@lumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with polycythaemia, requiring phlebotomy on a regular basis (at least every 4 months)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean heart rate as measured by the withings BPM and withings Steel HR biodevices	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.	one week before until one week after phlebotomy; for three phlebotomies

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Investigators: Principal Investigator: Jaap Jan Zwaginga, MD, PhD, LUMC

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Polycythemia
• Other Study ID Numbers: N22.055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Stored in non-publicly available repository, will be made available on request
• IPD Sharing Time Frame: After completion of trial
• IPD Sharing Access Criteria: available on request by contacting coordinating researcher
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No