Back to results

Serial Phlebotomy in Voluntary Blood Donors

Primary Purpose

Atherosclerosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Phlebotomy

About this trial

This is an interventional prevention trial for Atherosclerosis focused on measuring endothelial function, iron stores, red blood cell, blood donation

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

New York University Langone Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Phlebotomy plus normal saline

Phlebotomy plus intravenous iron

Sham Phlebotomy

Arm Description

Four serial phlebotomy procedures followed by infusion of normal saline

Four serial phlebotomy procedures followed by infusion of intravenous iron sucrose

Four serial sham phlebotomy procedures followed by infusion of normal saline

Outcomes

Primary Outcome Measures

Brachial artery reactivity response to oral methionine administration

Measure by vascular ultrasound imaging

Secondary Outcome Measures

Iron deficiency anemia

hemoglobin level measured by hemocue or complete blood count

Full Information

NCT ID

NCT02762422

First Posted

May 2, 2016

Last Updated

May 4, 2016

Sponsor

NYU Langone Health

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), National Center for Research Resources (NCRR)

1. Study Identification

Unique Protocol Identification Number

NCT02762422

Brief Title

Serial Phlebotomy in Voluntary Blood Donors

Official Title

Serial Phlebotomy in Voluntary Blood Donors

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

NYU Langone Health

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis

Keywords

endothelial function, iron stores, red blood cell, blood donation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phlebotomy plus normal saline

Arm Type

Experimental

Arm Description

Four serial phlebotomy procedures followed by infusion of normal saline

Arm Title

Phlebotomy plus intravenous iron

Arm Type

Experimental

Arm Description

Four serial phlebotomy procedures followed by infusion of intravenous iron sucrose

Arm Title

Sham Phlebotomy

Arm Type

Placebo Comparator

Arm Description

Four serial sham phlebotomy procedures followed by infusion of normal saline

Intervention Type

Other

Intervention Name(s)

Phlebotomy

Other Intervention Name(s)

Blood donation

Intervention Description

Removal of 500 cc of blood via forearm vein

Primary Outcome Measure Information:

Title

Brachial artery reactivity response to oral methionine administration

Description

Measure by vascular ultrasound imaging

Time Frame

Before and 1 week after completion of assigned phlebotomy procedures

Secondary Outcome Measure Information:

Title

Iron deficiency anemia

Description

hemoglobin level measured by hemocue or complete blood count

Time Frame

before each phlebotomy procedure, and at 1, 8, and 16 weeks after completion of assigned phlebotomy procedures

Other Pre-specified Outcome Measures:

Title

Serum ferritin

Time Frame

Before and 1 week after completion of assigned phlebotomy procedures

Title

Serum nitrotyrosine

Time Frame

Before and 1 week after completion of assigned phlebotomy procedures

Title

Whole blood viscosity

Time Frame

Before and 1 week after completion of assigned phlebotomy procedures

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stuart Katz, MD

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York University Langone Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Learn more about this trial

Serial Phlebotomy in Voluntary Blood Donors

We'll reach out to this number within 24 hrs