Serial Phlebotomy in Voluntary Blood Donors

Study Overview
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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.

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.

Official Title
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Serial Phlebotomy in Voluntary Blood Donors

Conditions
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Atherosclerosis

Intervention / Treatment
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* Other: Phlebotomy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phlebotomy plus normal saline<br>Four serial phlebotomy procedures followed by infusion of normal saline | Other: Phlebotomy<br>* Removal of 500 cc of blood via forearm vein<br>* Other names: Blood donation;|
| Experimental: Phlebotomy plus intravenous iron<br>Four serial phlebotomy procedures followed by infusion of intravenous iron sucrose | Other: Phlebotomy<br>* Removal of 500 cc of blood via forearm vein<br>* Other names: Blood donation;|
| Placebo Comparator: Sham Phlebotomy<br>Four serial sham phlebotomy procedures followed by infusion of normal saline | Other: Phlebotomy<br>* Removal of 500 cc of blood via forearm vein<br>* Other names: Blood donation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial artery reactivity response to oral methionine administration | Measure by vascular ultrasound imaging | Before and 1 week after completion of assigned phlebotomy procedures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron deficiency anemia | hemoglobin level measured by hemocue or complete blood count | before each phlebotomy procedure, and at 1, 8, and 16 weeks after completion of assigned phlebotomy procedures | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function, iron stores, red blood cell, blood donation