An observational study in Polycythemia, sponsored by Leiden University Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-13.
Sponsored by Leiden University Medical Center · Observational
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.
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:
Secondary Objectives:
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.
32 studies on the registry are indexed under Polycythemia; 12 are open to participants now.
Browse Polycythemia studies →Leiden University Medical Center is the lead sponsor of 334 studies on the registry; 110 are open to participants now.
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Patients with polycythaemia, requiring phlebotomy on a regular basis (at least every 4 months)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
500ml of blood phlebotomized per standard of care to reduce symptoms from polycythemia
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.
Time frame: one week before until one week after phlebotomy; for three phlebotomies
Systolic and diastolic blood pressure as measured by the withings BPM connect.
BP (systolic/diastolic) measured by 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
Steps as a measure for activity 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)
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)
Time frame: Daily basis from one week before until one week after phlebotomy; three phlebotomies
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Stored in non-publicly available repository, will be made available on request
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: After completion of trial
Access criteria: available on request by contacting coordinating researcher
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