Serial Phlebotomy in Voluntary Blood Donors

Not Applicable

Completed

• Conditions: Atherosclerosis
• Interventions: Other: Phlebotomy

• Registration Number: NCT02762422
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2016-05
• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-04
• Last Update Submitted: 2016-05-04
• Study First Posted: 2016-05-05
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phlebotomy plus normal saline	Phlebotomy	Four serial phlebotomy procedures followed by infusion of normal saline
Phlebotomy plus intravenous iron	Phlebotomy	Four serial phlebotomy procedures followed by infusion of intravenous iron sucrose
Sham Phlebotomy	Phlebotomy	Four serial sham phlebotomy procedures followed by infusion of normal saline

Primary Outcome Measures

Name	Time	Method
Brachial artery reactivity response to oral methionine administration	Before and 1 week after completion of assigned phlebotomy procedures	Measure by vascular ultrasound imaging

Secondary Outcome Measures

Name	Time	Method
Iron deficiency anemia	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

Trial Locations

Locations (1)

New York University Langone Medical Center; 🇺🇸 New York, New York, United States