Clincosm LogoSign in Get a demo

Serial Phlebotomy in Voluntary Blood Donors

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT02762422
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), National Center for Research Resources (NCRR) (NIH)
84
Enrollment
1
Location
3
Arms
38
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Phlebotomy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Serial Phlebotomy in Voluntary Blood Donors
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phlebotomy plus normal saline

Four serial phlebotomy procedures followed by infusion of normal saline

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

    		•
    Experimental: Phlebotomy plus intravenous iron

    Four serial phlebotomy procedures followed by infusion of intravenous iron sucrose

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

    		•
    Placebo Comparator: Sham Phlebotomy

    Four serial sham phlebotomy procedures followed by infusion of normal saline

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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 Outcome Measures

    1. Serum ferritin [Before and 1 week after completion of assigned phlebotomy procedures]

    2. Serum nitrotyrosine [Before and 1 week after completion of assigned phlebotomy procedures]

    3. Whole blood viscosity [Before and 1 week after completion of assigned phlebotomy procedures]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York University Langone Medical Center New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health
    • National Heart, Lung, and Blood Institute (NHLBI)
    • National Center for Research Resources (NCRR)

    Investigators

    • Principal Investigator: Stuart Katz, MD, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stuart Katz, Principal Investigator, NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT02762422
    Other Study ID Numbers:
    • 08-411
    • 1R01HL086932
    • UL1TR000038
    First Posted:
    May 5, 2016
    Last Update Posted:
    May 5, 2016
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Stuart Katz, Principal Investigator, NYU Langone Health
    endothelial function
    iron stores
    red blood cell
    blood donation
    Additional relevant MeSH terms:
    Atherosclerosis

    Study Results

    No Results Posted as of May 5, 2016