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OpenTrials
Completed

NCT Number: NCT01933035

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

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.

Completed

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Key information

Conditions

Immune Thrombocytopenia Anemia Anemia, Aplastic Anemia, Refractory Anemia, Refractory, with Excess of Blasts Aplastic Anaemia Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Bone Marrow Diseases Bone Marrow Failure Disorders Chemotherapy Induced Thrombocytopenia Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Myelodysplasia Myelodysplastic Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Roosevelt Hospital

New York, 10019, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immune Thrombocytopenics

Other

Full blood count with extended platelet parameters

Other names: MPC (g/dl), MPM (pg)

Hypo-proliferative thrombocytopenics

Other

Full blood count with extended platelet parameters

Other names: MPC (g/dl), MPM (pg)

Control Population

Other

Full blood count with extended platelet parameters

Other names: MPC (g/dl), MPM (pg)

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

Sponsors and collaborators

Lead sponsor

Beth Israel Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 30, 2013
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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