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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01933035
Other study ID # 13-0134
Secondary ID
Status Completed
Phase N/A
First received August 28, 2013
Last updated May 16, 2016
Start date October 2013
Est. completion date October 2015

Study information

Verified date May 2016
Source Beth Israel Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Other:
Immune Thrombocytopenics
Full blood count with extended platelet parameters
Hypo-proliferative thrombocytopenics
Full blood count with extended platelet parameters
Control Population
Full blood count with extended platelet parameters

Locations

Country Name City State
United States Roosevelt Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Platelet mass distribution width 12 Months No
Primary Increased platelet density 12 months No
Secondary mean platelet mass 12 months No
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