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

May 16, 2016 updated by: Beth Israel Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • Roosevelt hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population would consist of adult female and male subjects of all ethnic persuasions in good general health apart from thrombocytopenia, bone marrow aplasia, myelodysplasia, or active malignancy requiring therapy. Vulnerable strata of the hospital population will not be recruited into the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Immune Thrombocytopenics
Full blood count with extended platelet parameters
Other Names:
  • MPC (g/dl)
  • MPM (pg)
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.
Other: Hypo-proliferative thrombocytopenics
Full blood count with extended platelet parameters
Other Names:
  • MPC (g/dl)
  • MPM (pg)
Control Pupulation
comprised of healthy individuals with normal platelet counts, to confirm normal values for MPC and MPM
Other: Control Population
Full blood count with extended platelet parameters
Other Names:
  • MPC (g/dl)
  • MPM (pg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increased platelet density
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
mean platelet mass
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Time Frame
Platelet mass distribution width
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Medical Center

Investigators

  • Principal Investigator: Mala Varma, MD, Beth Israel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

August 28, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Estimate)

May 17, 2016

Last Update Submitted That Met QC Criteria

May 16, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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