Serial Phlebotomy in Voluntary Blood Donors

Atherosclerosis Clinical Trial

Official title:

Serial Phlebotomy in Voluntary Blood Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762422
• Other study ID #: 08-411
• Secondary ID: 1R01HL086932UL1T
• Status: Completed
• Phase: N/A
• First received: May 2, 2016
• Last updated: May 4, 2016
• Start date: June 2009
• Est. completion date: August 2012

Study information

• Verified date: May 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Other:
• Phlebotomy
Removal of 500 cc of blood via forearm vein

Locations

Country	Name	City	State
United States	New York University Langone Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University School of Medicine	National Center for Research Resources (NCRR), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum ferritin		Before and 1 week after completion of assigned phlebotomy procedures	No
Other	Serum nitrotyrosine		Before and 1 week after completion of assigned phlebotomy procedures	No
Other	Whole blood viscosity		Before and 1 week after completion of assigned phlebotomy procedures	No
Primary	Brachial artery reactivity response to oral methionine administration	Measure by vascular ultrasound imaging	Before and 1 week after completion of assigned phlebotomy procedures	No
Secondary	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	Yes