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

Completed

• Conditions: Myelodysplasia; Immune Thrombocytopenia; Aplastic Anaemia; Chemotherapy Induced Thrombocytopenia
• Interventions: Other: Hypo-proliferative thrombocytopenics; Other: Immune Thrombocytopenics; Other: Control Population

• Registration Number: NCT01933035
• Lead Sponsor: Beth Israel Medical Center

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.

Study Timeline

• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-08-28
• Study First Posted: 2013-08-30
• Study Start: 2013-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-16
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypo-proliferative 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.
Immune Thrombocytopenics	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.
Control Pupulation	Control Population	comprised of healthy individuals with normal platelet counts, to confirm normal values for MPC and MPM

Primary Outcome Measures

Name	Time	Method
Increased platelet density	12 months

Secondary Outcome Measures

Name	Time	Method
mean platelet mass	12 months

Trial Locations

Locations (1)

Roosevelt Hospital; 🇺🇸 New York, New York, United States