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

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 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

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