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

Beth Israel Lahey Health

Status: Completed

Conditions: Immune Thrombocytopenia; Chemotherapy Induced Thrombocytopenia; Myelodysplasia; Aplastic Anaemia

Treatments: Other: Hypo-proliferative thrombocytopenics; Other: Control Population; Other: Immune Thrombocytopenics

Study type: Observational

Funder types: Other

Identifiers

NCT01933035

13-0134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

50 participants in 3 patient groups

Immune Thrombocytopenics

Description:

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.

Treatment:

Other: Immune Thrombocytopenics

Hypo-proliferative thrombocytopenics

Description:

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.

Treatment:

Other: Hypo-proliferative thrombocytopenics

Control Pupulation

Description:

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

Treatment:

Other: Control Population