Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.
NCT ID: NCT01933035
Last Updated: 2016-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2013-10-31
2015-10-31
Brief Summary
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To develop the clinical potential of the extended platelet parameters as they pertain to distinguishing different causes of thrombocytopenia from one another.
To test the hypothesis that mean platelet component (MPC) and mean platelet mass (MPM) might distinguish between thrombocytopenia related to bone marrow dysfunction and immune mediated destruction of platelets.
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Detailed Description
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Inclusion criteria are as follows:
All individuals age 18yrs and above capable of rendering consent Known ITP confirmed by response to IVIG, glucocorticoids, or WinRho and exclusion of all other possible causes of thrombocytopenia Confirmed aplastic anemia \[as assessed through bone marrow trephine biopsy\]. Chemotherapy-induced thrombocytopenia assessed at time of predicted nadir.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Immune Thrombocytopenics
The study shall be a single institution prospective cohort study. Comparison will be made among individuals with known ITP . Those with known hypo-proliferative forms of thrombocytopenia \[aplastic anaemia, chemotherapy induced thrombocytopenia, and myelodysplastic thrombocytopenia, and a control population.
Immune Thrombocytopenics
Full blood count with extended platelet parameters
Hypo-proliferative thrombocytopenics
The study shall be a single institution prospective cohort study. Comparison will be made between individuals with known ITP versus those with known hypo-proliferative forms of thrombocytopenia \[aplastic anaemia, chemotherapy--induced thrombocytopenia, and myelodysplastic thrombocytopenia\], and a control population.
Hypo-proliferative thrombocytopenics
Full blood count with extended platelet parameters
Control Pupulation
comprised of healthy individuals with normal platelet counts, to confirm normal values for MPC and MPM
Control Population
Full blood count with extended platelet parameters
Interventions
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Immune Thrombocytopenics
Full blood count with extended platelet parameters
Hypo-proliferative thrombocytopenics
Full blood count with extended platelet parameters
Control Population
Full blood count with extended platelet parameters
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Known ITP confirmed by response to intravenous immune globulin (IVIG), glucocorticoids, or winRho and exclusion of all other possible causes of thrombocytopenia
* Confirmed aplastic anemia \[as assessed through bone marrow trephine biopsy\]
* Chemotherapy induced thrombocytopenia assessed at time of predicted nadir.
Exclusion Criteria
* Chronic active hepatitis
* Those infected with HIV
* Patients receiving concomitant radiotherapy
* Gravid females
* Congenital thrombocytopenias
18 Years
ALL
Yes
Sponsors
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Beth Israel Medical Center
OTHER
Responsible Party
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Principal Investigators
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Mala Varma, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Medical Center
Locations
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Roosevelt Hospital
New York, New York, United States
Countries
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Other Identifiers
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13-0134
Identifier Type: -
Identifier Source: org_study_id
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