Phlebotomy in Blood Donors and Polycythemia Vera Patients- The Effect on Physiology: An Orienting Case-Cross Over Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Mean heart rate as measured by the withings BPM and withings Steel HR biodevices
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Mean heart rate as measured by the withings BPM and withings Steel HR biodevices
时间窗: 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.
次要结局
- Number of steps per 24hrs as measured by the withings steel HR(one week before until one week after phlebotomy; for three phlebotomies)
- Systolic and diastolic blood pressure as measured by the withings BPM connect.(Daily basis from one week before until one week after phlebotomy; three phlebotomies)
- Quality of life as measured by the EuroQol-5D questionnaire (EQ5D)(Daily basis from one week before until one week after phlebotomy; three phlebotomies)
研究者
jjzwaginga
Prof. dr. J.J. Zwaginga
Leiden University Medical Center