Serial Phlebotomy in Voluntary Blood Donors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Phlebotomy plus normal saline

Four serial phlebotomy procedures followed by infusion of normal saline

Group Type EXPERIMENTAL

Phlebotomy

Intervention Type OTHER

Removal of 500 cc of blood via forearm vein

Phlebotomy plus intravenous iron

Four serial phlebotomy procedures followed by infusion of intravenous iron sucrose

Group Type EXPERIMENTAL

Phlebotomy

Intervention Type OTHER

Removal of 500 cc of blood via forearm vein

Sham Phlebotomy

Four serial sham phlebotomy procedures followed by infusion of normal saline

Group Type PLACEBO_COMPARATOR

Phlebotomy

Intervention Type OTHER

Removal of 500 cc of blood via forearm vein

Interventions

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Phlebotomy

Removal of 500 cc of blood via forearm vein

Intervention Type OTHER

Other Intervention Names

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Blood donation

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes