Brief Title
Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.
Official Title
Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.
Brief Summary
To utilise extended platelet parameters in order to individuate Immune Thrombocytopenia (ITP) from hypo-proliferative causes of thrombocytopenia. 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.
Detailed Description
Patient to be registered at the Haematology-Oncology department Mount Sinai Roosevelt Hospital. 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.
Study Type
Observational [Patient Registry]
Primary Outcome
Increased platelet density
Secondary Outcome
mean platelet mass
Condition
Immune Thrombocytopenia
Intervention
Immune Thrombocytopenics
Study Arms / Comparison Groups
Immune Thrombocytopenics
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
50
Start Date
October 2013
Completion Date
October 2015
Primary Completion Date
October 2015
Eligibility Criteria
Inclusion Criteria: - All individuals age 18yrs and above capable of rendering consent - 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: - Suspected multifactorial thrombocytopenias and thrombocytopenia due to hypersplenism - Chronic active hepatitis - Those infected with HIV - Patients receiving concomitant radiotherapy - Gravid females - Congenital thrombocytopenias
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Mala Varma, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01933035
Organization ID
13-0134
Responsible Party
Sponsor
Study Sponsor
Beth Israel Medical Center
Study Sponsor
Mala Varma, MD, Principal Investigator, Beth Israel Medical Center
Verification Date
May 2016