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

Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933035
• Other study ID #: 13-0134
• 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

Related Conditions & MeSH terms

• Anemia, Aplastic
• Aplastic Anaemia
• Chemotherapy Induced Thrombocytopenia
• Immune Thrombocytopenia
• Myelodysplasia
• Myelodysplastic Syndromes
• Preleukemia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

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