PolycythemiaNOSFERATUNCT05396170
Effect of Phlebotomy on Heartrate in Polycythemia Patients
An observational study of Polycythemia, run by Leiden University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia
- What is being tested?
- phlebotomy
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Jul 2022to 1 Jan 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with polycythaemia, requiring phlebotomy on a regular basis (at least every 4 months)
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
LUMC
Leiden, South Holland
Rik Tonino, MD, r.p.b.tonino@lumc.nl
Jaap Jan Zwaginga, MD, PhD, J.J.zwaginga@lumc.nl
About this study
Official title: Phlebotomy in Blood Donors and Polycythemia Vera Patients- The Effect on Physiology: An Orienting Case-Cross Over Study
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.
Read the 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.
- Conditions
- Polycythemia
- Being tested
- phlebotomy
- Medical subject headings
- Polycythemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phlebotomyProcedure or surgery
500ml of blood phlebotomized per standard of care to reduce symptoms from polycythemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
BP (systolic/diastolic) measured by Withings BPM connect
Measured: 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
Steps as a measure for activity as measured by the withings steel HR
Measured: one week before until one week after phlebotomy; for three phlebotomies
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)
Measured: Daily basis from one week before until one week after phlebotomy; three phlebotomies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start21 Jul 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolycythemiaStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jjzwaginga, Leiden University Medical Center
- Investigators
- Jaap Jan Zwaginga, MD, PhD, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396170
- Sponsor's protocol ID
- N22.055
- Acronym
- NOSFERATU
- Status last verified
- Nov 2024
- First submitted
- 25 May 2022
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Stored in non-publicly available repository, will be made available on request
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phlebotomy in Blood Donors and Polycythemia Vera Patients- The Effect on Physiology: An Orienting Case-Cross Over Study
- ClinicalTrials.gov ID
- NCT05396170
- Acronym / sponsor ID
- NOSFERATU / N22.055
- Conditions
- Polycythemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with polycythaemia, requiring phlebotomy on a regular basis (at least every 4 months)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phlebotomy500ml of blood phlebotomized per standard of care to reduce symptoms from polycythemia | Procedure or surgery | – |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: Yes. Stored in non-publicly available repository, will be made available on request
Related trials for Polycythemia
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 2/3
A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025).
Polycythemia Vera
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
RecruitingPhase 2
A Study of Ropeg-Interferon in People With Polycythemia Vera
Polycythemia Vera (PV), JAK2 Mutation
Active, not recruitingPhase 2
A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
Polycythemia Vera (PV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaap Jan Zwaginga, MD, PhD principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycythemia, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rik Tonino, MD (+31623248432, r.p.b.tonino@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.