Serial Phlebotomy in Voluntary Blood Donors

May 4, 2016 updated by: Stuart Katz, NYU Langone Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10016
        • New York University Langone Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phlebotomy plus normal saline
Four serial phlebotomy procedures followed by infusion of normal saline
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
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
Removal of 500 cc of blood via forearm vein
Other Names:
  • Blood donation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brachial artery reactivity response to oral methionine administration
Time Frame: Before and 1 week after completion of assigned phlebotomy procedures
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
Time Frame: 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
before each phlebotomy procedure, and at 1, 8, and 16 weeks after completion of assigned phlebotomy procedures

Other Outcome Measures

Outcome Measure
Time Frame
Serum ferritin
Time Frame: Before and 1 week after completion of assigned phlebotomy procedures
Before and 1 week after completion of assigned phlebotomy procedures
Serum nitrotyrosine
Time Frame: Before and 1 week after completion of assigned phlebotomy procedures
Before and 1 week after completion of assigned phlebotomy procedures
Whole blood viscosity
Time Frame: Before and 1 week after completion of assigned phlebotomy procedures
Before and 1 week after completion of assigned phlebotomy procedures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Estimate)

May 5, 2016

Last Update Submitted That Met QC Criteria

May 4, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 08-411
  • UL1TR000038 (U.S. NIH Grant/Contract)
  • 1R01HL086932 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

PI will make de-identified dataset available upon request in accord with institutional data use agreement policy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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