- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02762422
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
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:
|
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:
|
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:
|
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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
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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