Clincosm LogoSign in Get a demo

NOSFERATU: Effect of Phlebotomy on Heartrate in Polycythemia Patients

Sponsor
Leiden University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05396170
Collaborator
(none)
10
Enrollment
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Phlebotomy in Blood Donors and Polycythemia Vera Patients- The Effect on Physiology: An Orienting Case-Cross Over Study
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Outcome Measures

Primary Outcome Measures

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

  1. 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]

    BP (systolic/diastolic) measured by Withings BPM connect

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Leiden University Medical Center

Investigators

  • Principal Investigator: Jaap Jan Zwaginga, MD, PhD, LUMC

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
jjzwaginga, Prof. dr. J.J. Zwaginga, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT05396170
Other Study ID Numbers:
  • N22.055
First Posted:
May 31, 2022
Last Update Posted:
Jun 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Polycythemia

Study Results

No Results Posted as of Jun 6, 2022