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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL086932 | U.S. NIH Grant/Contract | View source | |
| UL1TR000038 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Center for Research Resources (NCRR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phlebotomy plus normal saline | Experimental | Four serial phlebotomy procedures followed by infusion of normal saline |
|
| Phlebotomy plus intravenous iron | Experimental | Four serial phlebotomy procedures followed by infusion of intravenous iron sucrose |
|
| Sham Phlebotomy | Placebo Comparator | Four serial sham phlebotomy procedures followed by infusion of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phlebotomy | Other | Removal of 500 cc of blood via forearm vein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brachial artery reactivity response to oral methionine administration | Measure by vascular ultrasound imaging | Before and 1 week after completion of assigned phlebotomy procedures |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum ferritin | Before and 1 week after completion of assigned phlebotomy procedures | |
| Serum nitrotyrosine | Before and 1 week after completion of assigned phlebotomy procedures | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Katz, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Langone Medical Center | New York | New York | 10016 | United States |
PI will make de-identified dataset available upon request in accord with institutional data use agreement policy
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D018962 | Phlebotomy |
| D000094345 | Blood Donation |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Whole blood viscosity |
| Before and 1 week after completion of assigned phlebotomy procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D009927 | Tissue and Organ Procurement |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |