Effect of Phlebotomy on Heartrate in Polycythemia Patients

Polycythemia Clinical Trial

— NOSFERATU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396170
• Other study ID #: N22.055
• Status: Recruiting
• Start date: July 21, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2023
• Source: Leiden University Medical Center
• Contact: Rik Tonino, MD
• Phone: +31623248432
• Email: r.p.b.tonino[@]lumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Polycythemia

Intervention

Procedure:
• phlebotomy
500ml of blood phlebotomized per standard of care to reduce symptoms from polycythemia

Locations

Country	Name	City	State
Netherlands	LUMC	Leiden	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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