HypertensionNCT01553409
Effect of Blood Donation on Blood Pressure, Iron Metabolism, Oxidative Stress
An observational study of Hypertension, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The investigators want to investigate the effects of blood donation to blood pressure, to iron metabolism and oxidative stress. There are results of other studies that show, that there is a positive effect of blood donation to high blood pressure, iron metabolism and oxidative stress. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to May 2014
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: female and male from 18 years to 65 years, who are able and want to donate blood for the first time or after one year break to the last blood donation
Who may be able to join
- first time donating blood or after a break of 12 months to last blood donation
- voluntary attending blood donation and study
- fulfilling the criteria of the blood donation center
Who cannot join
- criteria of the blood donation center (e. g. low haemoglobin, fever, acute infection, having spent in tropical countries for the last months,general bad health condition,...)
- missing informed consent to the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Universitätsmedizin Berlin Blutspende Campus Mitte
Berlin, 10117
About this study
Official title: Prospective Observational Study on the Effects of Blood Donation on Blood Pressure, Iron Metabolism and Oxidative Stress
The investigators want to investigate the effects of blood donation to blood pressure, to iron metabolism and oxidative stress.
There are results of other studies that show, that there is a positive effect of blood donation to high blood pressure, iron metabolism and oxidative stress.
Read the detailed description
The regular application flow of blood donation at that blood bank of Charité is not disturbed. There are only some more questions and measurement of blood pressure, iron metabolism, fat metabolism and oxidative stress.
No extra puncture of the vein is necessary.
- Conditions
- Hypertension
- Keywords
- Hypertension, Ferritin, Phlebotomy, Blood donation
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
seated blood pressure will be measured baseline and after 3 months by trained professionals
Measured: 3 months
Secondary outcomes (1)
blood pressure
seated blood pressure will be measured baseline and after 12 months by trained professionals
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Charite UniversityAbdulgabar Salama, Prof. Dr., Principal investigator, Charite University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553409
- Sponsor's protocol ID
- 89834103
- Status last verified
- May 2014
- First submitted
- 12 Mar 2012
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on the Effects of Blood Donation on Blood Pressure, Iron Metabolism and Oxidative Stress
- ClinicalTrials.gov ID
- NCT01553409
- Acronym / sponsor ID
- 89834103
- Conditions
- Hypertension
- Keywords
- Hypertension, Ferritin, Phlebotomy, Blood donation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 14 Mar 2012 (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.
The investigators want to investigate the effects of blood donation to blood pressure, to iron metabolism and oxidative stress.
There are results of other studies that show, that there is a positive effect of blood donation to high blood pressure, iron metabolism and oxidative stress.
Detailed description
The regular application flow of blood donation at that blood bank of Charité is not disturbed. There are only some more questions and measurement of blood pressure, iron metabolism, fat metabolism and oxidative stress.
No extra puncture of the vein is necessary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- female and male from 18 years to 65 years, who are able and want to donate blood for the first time or after one year break to the last blood donation
Key inclusion criteria (3 listed)
- first time donating blood or after a break of 12 months to last blood donation
- voluntary attending blood donation and study
- fulfilling the criteria of the blood donation center
Key exclusion criteria (2 listed)
- criteria of the blood donation center (e. g. low haemoglobin, fever, acute infection, having spent in tropical countries for the last months,general bad health condition,...)
- missing informed consent to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
blood pressure
Time frame: 3 months
seated blood pressure will be measured baseline and after 3 months by trained professionals
1 secondary outcome
blood pressure
Time frame: 12 months
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 8 May 2014.
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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.
Andreas Michalsen, Prof. Dr. principal investigator
Charite University
Abdulgabar Salama, Prof. Dr. principal investigator
Charite University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Charite University, Berlin, Germany at 1 site in Germany.
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 3 inclusion and 2 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 8 May 2014. 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 Germany. 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. 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?
blood pressure (time frame: 3 months). 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 8 May 2014.