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

NCT ID: NCT01933035

Last Updated: 2016-05-17

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Immune Thrombocytopenia Chemotherapy Induced Thrombocytopenia Myelodysplasia Aplastic Anaemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Full blood count with extended platelet parameters

Interventions

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Immune Thrombocytopenics

Full blood count with extended platelet parameters

Intervention Type OTHER

Hypo-proliferative thrombocytopenics

Full blood count with extended platelet parameters

Intervention Type OTHER

Control Population

Full blood count with extended platelet parameters

Intervention Type OTHER

Other Intervention Names

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MPC (g/dl) MPM (pg) MPC (g/dl) MPM (pg) MPC (g/dl) MPM (pg)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beth Israel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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13-0134

Identifier Type: -

Identifier Source: org_study_id

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