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NCT Number: NCT05396170

Effect of Phlebotomy on Heartrate in Polycythemia Patients

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.

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Key information

Conditions

Polycythemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LUMC

Leiden, South Holland, Netherlands

Location status: Recruiting

Location contact

Jaap Jan Zwaginga, MD, PhD

CONTACT

[email protected]

Rik Tonino, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phlebotomy

Procedure

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

Primary outcomes

  1. Mean heart rate as measured by the withings BPM and withings Steel HR biodevices

    Time frame: 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 outcomes

  1. Systolic and diastolic blood pressure as measured by the withings BPM connect.

    Time frame: Daily basis from one week before until one week after phlebotomy; three phlebotomies

    BP (systolic/diastolic) measured by Withings BPM connect

  2. Number of steps per 24hrs as measured by the withings steel HR

    Time frame: one week before until one week after phlebotomy; for three phlebotomies

    Steps as a measure for activity as measured by the withings steel HR

  3. Quality of life as measured by the EuroQol-5D questionnaire (EQ5D)

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jaap Jan Zwaginga, MD, PhD

CONTACT

[email protected]

071 526 9111 ext. +31

Rik Tonino, MD

CONTACT

[email protected]

+31623248432

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

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

Acronym: NOSFERATU

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
May 31, 2022
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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