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

Sponsor

Beth Israel Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01933035

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenia Chemotherapy Induced Thrombocytopenia Myelodysplasia Aplastic Anaemia	Other: Immune Thrombocytopenics Other: Hypo-proliferative thrombocytopenics Other: Control Population

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Full blood count with extended platelet parameters Other Names: MPC (g/dl) MPM (pg)
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 Full blood count with extended platelet parameters Other Names: MPC (g/dl) MPM (pg)
Control Pupulation comprised of healthy individuals with normal platelet counts, to confirm normal values for MPC and MPM	Other: Control Population Full blood count with extended platelet parameters Other Names: MPC (g/dl) MPM (pg)

Arm

Intervention/Treatment

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

Full blood count with extended platelet parameters

Other Names:

MPC (g/dl)

MPM (pg)

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

Full blood count with extended platelet parameters

Other Names:

MPC (g/dl)

MPM (pg)

Control Pupulation

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

Other: Control Population

Full blood count with extended platelet parameters

Other Names:

MPC (g/dl)

MPM (pg)

Outcome Measures

Primary Outcome Measures

Increased platelet density [12 months]

Secondary Outcome Measures

mean platelet mass [12 months]

Other Outcome Measures

Platelet mass distribution width [12 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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