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

NCT01933035 | Completed

• 1 other identifier: 13-0134
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Thrombocytopenia; Chemotherapy Induced Thrombocytopenia; Myelodysplasia; Aplastic Anaemia

Keywords

ITP; Thrombocytopenia; mean platelet mass; mean platelet component

Outcome Measures

Primary Outcomes (1)

• Increased platelet density

  12 months

Secondary Outcomes (1)

• mean platelet mass

  12 months

Other Outcomes (1)

• Platelet mass distribution width

  12 Months

Study Arms (3)

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

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

Control Pupulation

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

Other: Control Population

Interventions

Immune Thrombocytopenics OTHER

Full blood count with extended platelet parameters

Also known as: MPC (g/dl), MPM (pg)

Immune Thrombocytopenics

Hypo-proliferative thrombocytopenics OTHER

Full blood count with extended platelet parameters

Also known as: MPC (g/dl), MPM (pg)

Hypo-proliferative thrombocytopenics

Control Population OTHER

Full blood count with extended platelet parameters

Also known as: MPC (g/dl), MPM (pg)

Control Pupulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population would consist of adult female and male subjects of all ethnic persuasions in good general health apart from thrombocytopenia, bone marrow aplasia, myelodysplasia, or active malignancy requiring therapy. Vulnerable strata of the hospital population will not be recruited into the study.

You may qualify if:

• All individuals age 18yrs and above capable of rendering consent
• Confirmed aplastic anemia \[as assessed through bone marrow trephine biopsy\]
• Chemotherapy induced thrombocytopenia assessed at time of predicted nadir.

You may not qualify if:

• Suspected multifactorial thrombocytopenias and thrombocytopenia due to hypersplenism
• Chronic active hepatitis
• Those infected with HIV
• Patients receiving concomitant radiotherapy
• Gravid females
• Congenital thrombocytopenias

Sponsors & Collaborators

• Beth Israel Medical Center: lead

Study Sites (1)

Roosevelt Hospital

New York, New York, 10019, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Study subjects will have the following collected: Lavender tri-potassium EDTA tubes filled according to the manufacturer's specifications \[approximately 4ML of venous blood\], labeled, and promptly dispatched to the laboratory.The sample will be gently inverted several times prior to analysis on the ADVIA 120 taking care not to overly agitate the sample. Moreover, the specimen shall be inspected for clot formation prior to being assayed. The full blood count shall be obtained and in the configuration sub-menu the extended platelet parameter option shall be selected and thus actuated. A print out will be generated including the MPC, MPM, platelet component distribution width, platelet mass distribution width, and large platelet count in addition to the standard platelet count and mean platelet volume \[MPV\].

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Anemia, Refractory, with Excess of Blasts; Anemia, Aplastic; Thrombocytopenia

Interventions

1-methyl-1-piperidinomethane sulfonate; Population Control

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Anemia, Refractory; Anemia; Myelodysplastic Syndromes; Bone Marrow Diseases; Bone Marrow Failure Disorders

Intervention Hierarchy (Ancestors)

Population Dynamics; Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Mala Varma, MD

  Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: August 30, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

US (1)