Serial Phlebotomy in Voluntary Blood Donors

NCT02762422 — Not applicable, Completed, 84 participants, NYU Langone Health

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT02762422
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	84 (Actual)
Sponsor	NYU Langone Health (Other); collaborators: National Heart, Lung, and Blood Institute (NHLBI), National Center for Research Resources (NCRR)
Conditions	Atherosclerosis
Interventions	Phlebotomy (Other)
Dates	start 2009-06-01, primary completion 2012-08-01, completion 2012-08-01, first posted 2016-05-05, last updated 2016-05-05
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Phlebotomy plus normal saline	Experimental	Other: Phlebotomy	Four serial phlebotomy procedures followed by infusion of normal saline
Phlebotomy plus intravenous iron	Experimental	Other: Phlebotomy	Four serial phlebotomy procedures followed by infusion of intravenous iron sucrose
Sham Phlebotomy	Placebo comparator	Other: Phlebotomy	Four serial sham phlebotomy procedures followed by infusion of normal saline

Phlebotomy (Other), also known as Blood donation: Removal of 500 cc of blood via forearm vein

+Outcome measures

Primary outcomes

Brachial artery reactivity response to oral methionine administration [Before and 1 week after completion of assigned phlebotomy procedures]: Measure by vascular ultrasound imaging

Secondary outcomes

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

Other outcomes

Serum ferritin [Before and 1 week after completion of assigned phlebotomy procedures]
Serum nitrotyrosine [Before and 1 week after completion of assigned phlebotomy procedures]
Whole blood viscosity [Before and 1 week after completion of assigned phlebotomy procedures]

+Eligibility

Sex: All, ages: 40 Years to 70 Years, 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

+Locations (1)

Facility	City	Country	Status
New York University Langone Medical Center	New York, New York	United States

+Investigators

Stuart Katz, MD, Principal investigator, NYU Langone Health

+Funding

NIH grants: R01HL086932, UL1TR000038