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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:
- 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phlebotomy | Procedure | 500ml of blood phlebotomized per standard of care to reduce symptoms from polycythemia |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of steps per 24hrs as measured by the withings steel HR |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with polycythaemia, requiring phlebotomy on a regular basis (at least every 4 months)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rik Tonino, MD | Contact | +31623248432 | r.p.b.tonino@lumc.nl | |
| Jaap Jan Zwaginga, MD, PhD | Contact | 071 526 9111 | +31 | j.j.zwaginga@lumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Jaap Jan Zwaginga, MD, PhD | LUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LUMC | Recruiting | Leiden | South Holland | Netherlands |
Stored in non-publicly available repository, will be made available on request
After completion of trial
available on request by contacting coordinating researcher
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2022 | May 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011086 | Polycythemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D018962 | Phlebotomy |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Steps as a measure for activity as measured by the withings steel HR |
| 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) | Daily basis from one week before until one week after phlebotomy; three phlebotomies |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |