Serial Phlebotomy in Voluntary Blood Donors

NYU Langone Health

Status: Completed

Conditions: Atherosclerosis

Treatments: Other: Phlebotomy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02762422

1R01HL086932 (U.S. NIH Grant/Contract)

08-411

UL1TR000038 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 84 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 3 patient groups, including a placebo group

Phlebotomy plus normal saline

Experimental group

Description:

Four serial phlebotomy procedures followed by infusion of normal saline

Treatment:

Other: Phlebotomy

Phlebotomy plus intravenous iron

Experimental group

Description:

Four serial phlebotomy procedures followed by infusion of intravenous iron sucrose

Treatment:

Other: Phlebotomy

Sham Phlebotomy

Placebo Comparator group

Description:

Four serial sham phlebotomy procedures followed by infusion of normal saline

Treatment:

Other: Phlebotomy