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Completed

NCT Number: NCT02762422

Serial Phlebotomy in Voluntary Blood Donors

Blood donation has been proposed to be associated with reduced risk of cardiovascular disease, but the effects of phlebotomy on vascular function in human subjects have not been well characterized. A prospective randomized double-blind study was undertaken to determine the effects of iron loss and red blood cell loss induced by serial phlebotomy on vascular endothelial function in the brachial artery.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University Langone Medical Center

New York, 10016, United States

About this study

84 Fe-replete, non-anemic subjects were randomly assigned to one of three experimental serial phlebotomy procedures designed to induce Fe loss or RBC loss. Brachial artery reactivity (BAR, %) in response to transient oxidative stress induced by oral methionine was measured with high-resolution duplex ultrasound imaging before and after study phlebotomy procedures.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hemoglobin levels >13.5 g/dl for men, or >12.5 g/dl for women
  • serum ferritin 50-400 ng/ml

Exclusion criteria

  • known intolerance of phlebotomy procedures
  • major trauma or surgical procedures in the last 2 years
  • menstrual or other uterine bleeding in the last 2 years
  • chronic oral anticoagulation or dual antiplatelet therapy
  • chronic non-steroidal anti-inflammatory drug use
  • known history of hemochromatosis or other disorder of hematopoiesis or Fe metabolism
  • chronic oral Fe supplementation other than Fe-containing multivitamins
  • history of active cancer in the past 2 years
  • known history of chronic inflammatory disease
  • uncontrolled hypertension
  • electrocardiographic evidence of prior myocardial infarction
  • diabetes mellitus
  • fasting glucose >100 mg/dL
  • body mass index >40 kg/m2
  • any tobacco use in the past 6 months

Treatment and study plan

Phlebotomy

Other

Removal of 500 cc of blood via forearm vein

Other names: Blood donation

Primary outcomes

  1. Brachial artery reactivity response to oral methionine administration

    Time frame: Before and 1 week after completion of assigned phlebotomy procedures

    Measure by vascular ultrasound imaging

Secondary outcomes

  1. Iron deficiency anemia

    Time frame: before each phlebotomy procedure, and at 1, 8, and 16 weeks after completion of assigned phlebotomy procedures

    hemoglobin level measured by hemocue or complete blood count

Other outcomes

  1. Serum ferritin

    Time frame: Before and 1 week after completion of assigned phlebotomy procedures

  2. Serum nitrotyrosine

    Time frame: Before and 1 week after completion of assigned phlebotomy procedures

  3. Whole blood viscosity

    Time frame: Before and 1 week after completion of assigned phlebotomy procedures

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 5, 2016
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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