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NCT05396170Recruiting

Effect of Phlebotomy on Heartrate in Polycythemia Patients

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

Source: ClinicalTrials.gov · Last updated 13 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
10 (estimated)
First submitted
25 May 2022
Start date
21 Jul 2022
Primary completion date
31 Dec 2024
Lead sponsor
Leiden University Medical Center
NCT number
NCT05396170

What you commit to

  • Study type: Observational
  • Planned participants: 10
  • From 21 Jul 2022 to the primary completion date, 31 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Scheduled oncological treatments or surgery during the study period.

Other illness

  • Participants with known arrhythmias or other significant cardiological conductivity disorders (Paroxysmal atrial fibrillation is allowed)

Other

  • Poor performance/functional status (Eastern Cooperative Oncology Group system ECOG ≥3)
  • Hospitalized subjects
  • Subjects with a pacemaker.
  • Subjects with a secondary polyglobulia due to eg smoking or other pulmonary issues.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
LUMC
Coordinator of this site? Confirm its status
LeidenNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.