CClinicalTrials.gg
CompletedNCT01933035Updated May 17, 2016

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

An observational study in Immune Thrombocytopenia, Chemotherapy Induced Thrombocytopenia and Myelodysplasia, sponsored by Beth Israel Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-17.

Sponsored by Beth Israel Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Immune Thrombocytopenia
  • Chemotherapy Induced Thrombocytopenia
  • Myelodysplasia
  • Aplastic Anaemia

Keywords

  • ITP
  • Thrombocytopenia
  • mean platelet mass
  • mean platelet component
03

In context

Preleukemia

1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.

This study's enrollment of 50 is below the median of 114 across 116 observational studies indexed under Preleukemia.

Browse Preleukemia studies →

Lead sponsor

Beth Israel Medical Center is the lead sponsor of 50 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Target follow-up
12 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • 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

  • Control Pupulation

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

    Other: Control Population

Interventions

  • OtherImmune Thrombocytopenics

    Full blood count with extended platelet parameters

    Also known as: MPC (g/dl), MPM (pg)

  • OtherHypo-proliferative thrombocytopenics

    Full blood count with extended platelet parameters

    Also known as: MPC (g/dl), MPM (pg)

  • OtherControl Population

    Full blood count with extended platelet parameters

    Also known as: MPC (g/dl), MPM (pg)

06

What researchers measure

Primary outcomes

  1. Increased platelet density

    Time frame: 12 months

Secondary outcomes

  1. mean platelet mass

    Time frame: 12 months

Other outcomes

  1. Platelet mass distribution width

    Time frame: 12 Months

07

Study locations

1 site
  • Roosevelt Hospital
    New York, New York 10019, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01933035
Lead sponsor
Beth Israel Medical Center
Responsible party
Sponsor
First posted
Aug 30, 2013
Start date
Oct 2013
Primary completion
Oct 2015
Completion
Oct 2015
Last update
May 17, 2016

Study contacts

Mala Varma, MD
principal investigator · Beth Israel Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion