Actively Recruiting
Phlebotomy in Blood Donors and Polycythemia Vera Patients - The Effect on Physiology: An Orienting Case-Cross Over Study
Led by Leiden University Medical Center · Updated on 2024-11-13
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of phlebotomy, a blood removal procedure, on heart rate and other physical functions in adults with polycythemia who need regular phlebotomies. This observational study aims to understand how changes in hemoglobin levels affect patient physiology, quality of life, and activity, helping to guide treatment decisions for anemia, blood donation safety, and polycythemia management. Participants will be monitored continuously using wearable devices starting one week before a phlebotomy and continuing until one week after, across three separate phlebotomy events. The study collects data on heart rate, blood pressure, physical activity, and quality of life through devices like the Withings BPM and Steel HR, and questionnaires such as the EuroQol-5D. During the study, patients will wear monitoring devices and complete daily quality of life questionnaires. Researchers will track heart rate and blood pressure daily for one week before and after each phlebotomy. The main measure is the average heart rate around phlebotomy events. This remote monitoring approach helps assess physical changes and well-being over the course of treatment, with participation lasting through three phlebotomies.
CONDITIONS
Brief Title
Effect of Phlebotomy on Heartrate in Polycythemia Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with polycythemia requiring phlebotomy at least every 4 months
- Age 18 years or older
- Own a smartphone
- Life expectancy of at least 3 months
You will not qualify if you...
- Poor functional status (ECOG 3 or higher)
- Known arrhythmias or significant heart conduction disorders (except paroxysmal atrial fibrillation)
- Currently hospitalized
- Presence of a pacemaker
- Secondary polyglobulia due to smoking or lung problems
- Scheduled cancer treatments or surgery during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 2 weeks per phlebotomy session
Participants are remotely monitored to assess heart rate, blood pressure, activity levels, and quality of life before and after phlebotomy.
Daily remote monitoring from 1 week before until 1 week after each phlebotomy; for three phlebotomies
Trial Site Locations
Total: 1 location
1
LUMC
Leiden, South Holland, Netherlands
Actively Recruiting
Research Team
R
Rik Tonino, MD
J
Jaap Jan Zwaginga, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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