Sickle Cell DiseaseNCT00226083
Study of Blood Platelets in Sickle Cell Disease
An observational study of Sickle Cell Disease, run by Rockefeller University at 1 site in United States.
Trial summary
We are studying if sickle cell disease blood platelets are larger than normal and how they may cause obstruction of blood vessels. We are also trying to study the reasons why large platelets are found in patients with sickle cell disease. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Sep 2007
- 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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults and children with sickle cell disease (Hb SS)
Who may be able to join
- Adults and children > 7 years of age with sickle cell disease (Hb SS) who are not taking hydroxyurea and are not receiving routine blood transfusion therapy.
Who cannot join
- Current hydroxyurea therapy or,
- Hydroxyurea use within the past 3 months
- Blood transfusion or exchange transfusion within the past 3 months
- Current treatment with aspirin or clopidogrel
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockefeller University Hospital
New York, New York, 10021
About this study
Official title: Studies of Large Platelets in Patients With Sickle Cell Disease
We are studying if sickle cell disease blood platelets are larger than normal and how they may cause obstruction of blood vessels. We are also trying to study the reasons why large platelets are found in patients with sickle cell disease.
Read the detailed description
Research volunteers are seen in the Outpatient Research Center by the Principal Investigator or another physician. A detailed history is obtained, a physical examination is performed, and blood (usually 4 tablespoons) is obtained for additional tests. The research volunteer's previous medical records will be requested. Upto 5 additional blood samples may be obtained in a subgroup of patients.
- Conditions
- Sickle Cell Disease
- Medical subject headings
- Anemia, Sickle Cell
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionSep 2007 (estimated)
- Study completionSep 2007 (estimated)
Why it stopped: PI returned to India
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Schneider Children's Hospital of North Shore
- Responsible party
- Sponsor
- Investigators
- Arun Shet, MD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226083
- Sponsor's protocol ID
- RUH IRB # AST-0565-0805
- Status last verified
- Jun 2015
- First submitted
- 22 Sep 2005
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Large Platelets in Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT00226083
- Acronym / sponsor ID
- RUH IRB # AST-0565-0805
- Conditions
- Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI returned to India
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Schneider Children's Hospital of North Shore
- Study start
- Aug 2005
- Primary completion
- Sep 2007 (estimated)
- Study completion
- Sep 2007 (estimated)
- First posted
- 26 Sep 2005 (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.
We are studying if sickle cell disease blood platelets are larger than normal and how they may cause obstruction of blood vessels. We are also trying to study the reasons why large platelets are found in patients with sickle cell disease.
Detailed description
Research volunteers are seen in the Outpatient Research Center by the Principal Investigator or another physician. A detailed history is obtained, a physical examination is performed, and blood (usually 4 tablespoons) is obtained for additional tests. The research volunteer's previous medical records will be requested. Upto 5 additional blood samples may be obtained in a subgroup of patients.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children with sickle cell disease (Hb SS)
Key inclusion criteria (1 listed)
- Adults and children > 7 years of age with sickle cell disease (Hb SS) who are not taking hydroxyurea and are not receiving routine blood transfusion therapy.
Key exclusion criteria (4 listed)
- Current hydroxyurea therapy or,
- Hydroxyurea use within the past 3 months
- Blood transfusion or exchange transfusion within the past 3 months
- Current treatment with aspirin or clopidogrel
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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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.
Arun Shet, MD principal investigator
Rockefeller 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 Sickle Cell Disease, run by Rockefeller University 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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 9 Jun 2015. 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. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 9 Jun 2015.