Iron Deficiency AnemiasNCT02129907
The Purpose of the Study is to Examine Whether Iron Deficiency Anemia is Associated With Increased Production of Thrombin and Whether Correction of Anemia by Providing Iron Intravenously Causes a Significant Reduction in Production of Thrombin.
An observational study of Iron Deficiency Anemias, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
In total 50 subjects with iron deficiency anemia treated with intravenous iron are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant before iron treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemias
- How many people
- 82 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to Dec 2015
- How long will I take part?
- 10 Weeks
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: men and women over age 18 suffering from iron deficiency anemia that wasnt responded to oral iron treatment or there is contraindication for oral iron therapy.
Who may be able to join
- age >18 years
- Iron deficiency anemia that did not response to oral iron treatment and is planned to receive iron supplement intravenously.
- Signing the informed consent
Who cannot join
- chronic inflammatory disease
- renal failure
- Malignancy
- Infectious disease
- Other reason for anemia except iron deficiency anemia.
- Pregnant women
- Use of anti aggregating agents or anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
In total 50 subjects with iron deficiency anemia treated with intravenous iron are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant before iron treatment. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). patient will go face to face interview and will be asked to answer structured questionnaire which will include information on demographics, clinical data ( fever, allergies , etc.) and comorbidities
Two weeks after completing intravenous iron administration additional blood samples will be taken: thrombin generation will be measured
- Conditions
- Iron Deficiency Anemias
- Keywords
- Anemias, Iron-Deficiency, thrombin
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
thrombin generation levels
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiasStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
- Target duration
- 10 Weeks
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elias mazen, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129907
- Sponsor's protocol ID
- thrombingeneration- anemia
- Status last verified
- Dec 2015
- First submitted
- 1 May 2014
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Purpose of the Study is to Examine Whether Iron Deficiency Anemia is Associated With Increased Production of Thrombin and Whether Correction of Anemia by Providing Iron Intravenously Causes a Significant Reduction in Production of Thrombin.
- ClinicalTrials.gov ID
- NCT02129907
- Acronym / sponsor ID
- thrombingeneration- anemia
- Conditions
- Iron Deficiency Anemias
- Keywords
- Anemias, Iron-Deficiency, thrombin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 May 2014 (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.
In total 50 subjects with iron deficiency anemia treated with intravenous iron are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant before iron treatment. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). patient will go face to face interview and will be asked to answer structured questionnaire which will include information on demographics, clinical data ( fever, allergies , etc.) and comorbidities
Two weeks after completing intravenous iron administration additional blood samples will be taken: thrombin generation will be measured
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men and women over age 18 suffering from iron deficiency anemia that wasnt responded to oral iron treatment or there is contraindication for oral iron therapy.
Key inclusion criteria (3 listed)
- age >18 years
- Iron deficiency anemia that did not response to oral iron treatment and is planned to receive iron supplement intravenously.
- Signing the informed consent
Key exclusion criteria (7 listed)
- chronic inflammatory disease
- renal failure
- Malignancy
- Infectious disease
- Other reason for anemia except iron deficiency anemia.
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
thrombin generation levels
Time frame: 10 weeks
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 19 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Iron Deficiency Anemias, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 7 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 19 Dec 2018. 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 Israel. 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?
thrombin generation levels (time frame: 10 weeks). 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 19 Dec 2018.