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Immune Thrombocytopenia | Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.

Immune Thrombocytopenia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Immune Thrombocytopenia

Chemotherapy Induced Thrombocytopenia

Myelodysplasia

Aplastic Anaemia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Immune ThrombocytopenicsFull blood count with extended platelet parameters

Other:Hypo-proliferative thrombocytopenicsFull blood count with extended platelet parameters

Other:Control PopulationFull blood count with extended platelet parameters

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Immune ThrombocytopenicsThe 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.

Hypo-proliferative thrombocytopenicsThe 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.

Control Pupulationcomprised of healthy individuals with normal platelet counts, to confirm normal values for MPC and MPM

Study Status

Completed

Start Date: October 2013

Completed Date: October 2015

Phase:

Type: Observational [Patient Registry]

Design:

Primary Outcome: Increased platelet density

Secondary Outcome: mean platelet mass

Study sponsors, principal investigator, and references

Principal Investigator: Mala Varma, MD

Lead Sponsor: Beth Israel Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01933035

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