Central Hemodynamics, Augmentation index and Microcirculation after Phlebotomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27853

Enrollment

Registered

2013-06-11

Start date

2013-06-11

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Augmentation index Central blood pressure Phlebotomy Microcirculation Plasma viscocity Augmentatie index Centrale bloeddruk Aderlating Microcirculatie Plasmaviscociteit

Interventions

Phlebotomy with or without volume replacement. Each patient serves as his or her own control. The hemodynamic measurements from before the phlebotomy (500ml) are compared to the hemodynamic measuremen

Eligibility

Inclusion criteria

Inclusion criteria: - Patients aged 18-75 years receiving phlebotomy at regular intervals (for example because of hemochromatosis or polycythemia vera) ; - Willing to participate ; - Able to provide informed consent.

Exclusion criteria

Exclusion criteria: - Pacemaker or ICD device ; - Atrial fibrillation ; - Mechanical heart valve ; - Congestive heart failure (≥NYHA III/IV) ; - Unable to stand up ; - Uncontrolled hypertension (BP>180/110 mmHg).

Design outcomes

Primary

Measure	Time frame
The principal endpoint is defined as the difference in AIx (≥4%) before and after phlebotomy while standing.	—

Secondary

Measure	Time frame
Difference in central BP before and after phlebotomy while standing • Differences in AIx and central BP before and after phlebotomy while supine • Differences in AIX and central BP following the effects of counter manoeuvres (leg crossing and thigh compression) before and after phlebotomy while standing • Differences in stroke volume, heart rate and systemic vascular resistance before and after phlebotomy while supine and after standing • Differences in forward and backward wave analysis before and after phlebotomy while supine and after standing • Differences in baroreflex sensitivity before and after phlebotomy while supine and after standing • Differences in AIx and central BP after phlebotomy and after compensatory saline infusion while supine and after standing • Differences in stroke volume, heart rate and systemic vascular resistance after phlebotomy and after compensatory saline infusion while supine and after standing • Differences in forward and backward wave analysis after phlebotomy and after compensatory saline infusion while supine and after standing • Differences in forward and backward wave analysis after phlebotomy and after compensatory saline infusion while supine and after standing • Differences in AIX and central BP following the effects of counter manoeuvres (leg crossing and thigh compression) minutes after phlebotomy and after compensatory saline infusion • Difference in microcirculation before and after phlebotomy with or without volume replacement.	—

Measure

Time frame

Difference in central BP before and after phlebotomy while standing • Differences in AIx and central BP before and after phlebotomy while supine • Differences in AIX and central BP following the effects of counter manoeuvres (leg crossing and thigh compression) before and after phlebotomy while standing • Differences in stroke volume, heart rate and systemic vascular resistance before and after phlebotomy while supine and after standing • Differences in forward and backward wave analysis before and after phlebotomy while supine and after standing • Differences in baroreflex sensitivity before and after phlebotomy while supine and after standing • Differences in AIx and central BP after phlebotomy and after compensatory saline infusion while supine and after standing • Differences in stroke volume, heart rate and systemic vascular resistance after phlebotomy and after compensatory saline infusion while supine and after standing • Differences in forward and backward wave analysis after phlebotomy and after compensatory saline infusion while supine and after standing • Differences in forward and backward wave analysis after phlebotomy and after compensatory saline infusion while supine and after standing • Differences in AIX and central BP following the effects of counter manoeuvres (leg crossing and thigh compression) minutes after phlebotomy and after compensatory saline infusion • Difference in microcirculation before and after phlebotomy with or without volume replacement.

—

Contacts

Public ContactN.V. Hoeven, van der

Academisch Medisch Centrum Meibergdreef 9

n.v.vanderhoeven@amc.uva.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)