AtherosclerosisNCT02762422
Serial Phlebotomy in Voluntary Blood Donors
A study testing Phlebotomy in people with Atherosclerosis, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Phlebotomy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- hemoglobin levels >13.5 g/dl for men, or >12.5 g/dl for women
- serum ferritin 50-400 ng/ml
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Langone Medical Center
New York, New York, 10016
About this study
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.
Read the 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.
- Conditions
- Atherosclerosis
- Being tested
- Phlebotomy
- Keywords
- endothelial function, iron stores, red blood cell, blood donation
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhlebotomyOther
Also called Blood donation
Removal of 500 cc of blood via forearm vein
| Study group | Role | What they receive |
|---|---|---|
| Phlebotomy plus normal saline | Experimental | Four serial phlebotomy procedures followed by infusion of normal saline Receives: Other: Phlebotomy |
| Phlebotomy plus intravenous iron | Experimental | Four serial phlebotomy procedures followed by infusion of intravenous iron sucrose Receives: Other: Phlebotomy |
| Sham Phlebotomy | Placebo comparator | Four serial sham phlebotomy procedures followed by infusion of normal saline Receives: Other: Phlebotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery reactivity response to oral methionine administration
Measure by vascular ultrasound imaging
Measured: Before and 1 week after completion of assigned phlebotomy procedures
Secondary outcomes (1)
Iron deficiency anemia
hemoglobin level measured by hemocue or complete blood count
Measured: before each phlebotomy procedure, and at 1, 8, and 16 weeks after completion of assigned phlebotomy procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJun 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Stuart Katz, NYU Langone Health
- Investigators
- Stuart Katz, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762422
- Sponsor's protocol ID
- 08-411
- Other IDs
- 1R01HL086932, UL1TR000038
- Status last verified
- May 2016
- First submitted
- 2 May 2016
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: PI will make de-identified dataset available upon request in accord with institutional data use agreement policy
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Phlebotomy in Voluntary Blood Donors
- ClinicalTrials.gov ID
- NCT02762422
- Acronym / sponsor ID
- 08-411
- Conditions
- Atherosclerosis
- Keywords
- endothelial function, iron stores, red blood cell, blood donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Center for Research Resources (NCRR)
- Study start
- Jun 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phlebotomy plus normal saline | Experimental | Other: PhlebotomyFour serial phlebotomy procedures followed by infusion of normal saline |
| Phlebotomy plus intravenous iron | Experimental | Other: PhlebotomyFour serial phlebotomy procedures followed by infusion of intravenous iron sucrose |
| Sham Phlebotomy | Placebo comparator | Other: PhlebotomyFour serial sham phlebotomy procedures followed by infusion of normal saline |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hemoglobin levels >13.5 g/dl for men, or >12.5 g/dl for women
- serum ferritin 50-400 ng/ml
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhlebotomyAlso: Blood donationRemoval of 500 cc of blood via forearm vein | Other | Phlebotomy plus intravenous iron, Phlebotomy plus normal saline, Sham Phlebotomy |
Primary outcome
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
1 secondary outcome
Iron deficiency anemia
Time frame: before each phlebotomy procedure, and at 1, 8, and 16 weeks after completion of assigned phlebotomy procedures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Individual participant dataSharing planned: Yes. PI will make de-identified dataset available upon request in accord with institutional data use agreement policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Katz, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phlebotomy in people with Atherosclerosis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial artery reactivity response to oral methionine administration (time frame: Before and 1 week after completion of assigned phlebotomy procedures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.