Effect of Phlebotomy on Heartrate in Polycythemia Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: phlebotomy.
- Кому может быть актуально
- Состояния в реестре: Polycythemia. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Phlebotomy in Blood Donors and Polycythemia Vera Patients- The Effect on Physiology: An Orienting Case-Cross Over Study
Обзор
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.
Подробное описание
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.
Вмешательства
- Процедура phlebotomy
500ml of blood phlebotomized per standard of care to reduce symptoms from polycythemia
Первичные конечные точки
- Mean heart rate as measured by the withings BPM and withings Steel HR biodevices [Срок оценки: one week before until one week after phlebotomy; for three phlebotomies]
Вторичные конечные точки (3)
- Systolic and diastolic blood pressure as measured by the withings BPM connect. [Срок оценки: 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 [Срок оценки: one week before until one week after phlebotomy; for three phlebotomies]
- Quality of life as measured by the EuroQol-5D questionnaire (EQ5D) [Срок оценки: Daily basis from one week before until one week after phlebotomy; three phlebotomies]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Нидерланды · 1 центр
- LUMC — Leiden
Идентификаторы
NCT: NCT05396170 · N22.055