Clinical trial NCT01933035: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Thrombocytopenia
Chemotherapy Induced Thrombocytopenia
Myelodysplasia
Aplastic Anaemia
Keywords: ITP
Thrombocytopenia
mean platelet mass
mean platelet component
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Increased platelet density
timeFrame: 12 months
Secondary outcomes:
measure: mean platelet mass
timeFrame: 12 months
Other outcomes:
measure: Platelet mass distribution width
timeFrame: 12 Months
Locations:
city: New York
country: United States
facility: Roosevelt Hospital
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Mala Varma, MD
role: PRINCIPAL_INVESTIGATOR
References: