Effect of Phlebotomy on Heartrate in Polycythemia Patients

NCT05396170 | Recruiting

• 1 other identifier: N22.055
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycythemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Number of steps per 24hrs 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)

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

Interventions

phlebotomy PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

LUMC

Leiden, South Holland, Netherlands

RECRUITING

MeSH Terms

Conditions

Polycythemia

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jaap Jan Zwaginga, MD, PhD

  LUMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rik Tonino, MD

CONTACT

+31623248432; r.p.b.tonino@lumc.nl

Jaap Jan Zwaginga, MD, PhD

CONTACT

071 526 9111; j.j.zwaginga@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. J.J. Zwaginga

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: July 21, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: After completion of trial
• Access Criteria: available on request by contacting coordinating researcher

Locations

NL (1)