Sickle Cell AnemiaNCT00512226
Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia
A study testing Cardiac and Liver T2* MRI in people with Sickle Cell Anemia and Sickle Cell Thalassemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Iron overload is well study in Thalassemia patients and it's not only related to blood transfusions, since intestinal iron absorption is also increased in those patients. Sickle cell patients didn't develope significant clinical symptoms and signs of iron overload in spite frequent transfusions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Anemia, Sickle Cell Thalassemia, Iron Overload
- What is being tested?
- Cardiac and Liver T2* MRI
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to Dec 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All the patients with Sickle cell anemia and Sickle cell Thalasemia that are currently in follow up at the Pediatric Hematology Unit
Who cannot join
- Age below 18 years.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Afula, 18101
About this study
Official title: Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia Using T2* Cardiac MRI.
Iron overload is well study in Thalassemia patients and it's not only related to blood transfusions, since intestinal iron absorption is also increased in those patients. Sickle cell patients didn't develope significant clinical symptoms and signs of iron overload in spite frequent transfusions. The purpouse of this study is to assess the iron overload in Sickle cell anemia and Sickle cell Thalassemia patients using clinical parameters and cardiac T2*MRI in order to determine the cardiac and liver iron.
- Conditions
- Sickle Cell Anemia, Sickle Cell Thalassemia, Iron Overload, MRI
- Being tested
- Cardiac and Liver T2* MRI
- Keywords
- Sickle Cell Anemia, Sickle Cell Thalassemia, Iron Overload, MRI
- Medical subject headings
- Anemia, Sickle Cell, Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac and Liver T2* MRIOther
Laboratory examinations that are routinely used in follow up of those patients and T2* MRI analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Iron overload.
Measured: December 2008
Secondary outcomes (1)
Institute the criteria for iron chelator treatment
Measured: December 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell AnemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Wolfson Medical Center
- Responsible party
- Principal investigator, Dr Koren Ariel, HaEmek Medical Center, Israel
- Investigators
- Ariel Koren, MD, Principal investigator, Pediatric Hematology Unit, Ha'Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512226
- Sponsor's protocol ID
- 0037-07-EMC
- Status last verified
- Aug 2011
- First submitted
- 5 Aug 2007
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia Using T2* Cardiac MRI.
- ClinicalTrials.gov ID
- NCT00512226
- Acronym / sponsor ID
- 0037-07-EMC
- Conditions
- Sickle Cell Anemia, Sickle Cell Thalassemia, Iron Overload, MRI
- Keywords
- Sickle Cell Anemia, Sickle Cell Thalassemia, Iron Overload, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- Wolfson Medical Center
- Study start
- Sep 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Aug 2007 (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.
Iron overload is well study in Thalassemia patients and it's not only related to blood transfusions, since intestinal iron absorption is also increased in those patients. Sickle cell patients didn't develope significant clinical symptoms and signs of iron overload in spite frequent transfusions. The purpouse of this study is to assess the iron overload in Sickle cell anemia and Sickle cell Thalassemia patients using clinical parameters and cardiac T2*MRI in order to determine the cardiac and liver iron.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All the patients with Sickle cell anemia and Sickle cell Thalasemia that are currently in follow up at the Pediatric Hematology Unit
Key exclusion criteria (1 listed)
- Age below 18 years.
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 |
|---|---|---|
| Cardiac and Liver T2* MRILaboratory examinations that are routinely used in follow up of those patients and T2* MRI analysis. | Other | – |
Primary outcome
Assessment of Iron overload.
Time frame: December 2008
1 secondary outcome
Institute the criteria for iron chelator treatment
Time frame: December 2008
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 26 Aug 2011.
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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.
Ariel Koren, MD principal investigator
Pediatric Hematology Unit, Ha'Emek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac and Liver T2* MRI in people with Sickle Cell Anemia and Sickle Cell Thalassemia, 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 1 inclusion and 1 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 26 Aug 2011. 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?
Assessment of Iron overload. (time frame: December 2008). 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 26 Aug 2011.