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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01933035
First received: August 28, 2013
Last updated: May 16, 2016
Last verified: May 2016
  Purpose

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 Intervention
Immune Thrombocytopenia
Chemotherapy Induced Thrombocytopenia
Myelodysplasia
Aplastic Anaemia
Other: Immune Thrombocytopenics
Other: Hypo-proliferative thrombocytopenics
Other: Control Population

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.

Resource links provided by NLM:


Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • Increased platelet density [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean platelet mass [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Platelet mass distribution width [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

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].

Enrollment: 50
Study Start Date: October 2013
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933035

Locations
United States, New York
Roosevelt Hospital
New York, New York, United States, 10019
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
Principal Investigator: Mala Varma, MD Beth Israel Medical Center
  More Information

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01933035     History of Changes
Other Study ID Numbers: 13-0134 
Study First Received: August 28, 2013
Last Updated: May 16, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Medical Center:
ITP
Thrombocytopenia
mean platelet mass
mean platelet component

Additional relevant MeSH terms:
Thrombocytopenia
Anemia, Aplastic
Purpura, Thrombocytopenic, Idiopathic
Myelodysplastic Syndromes
Preleukemia
Blood Platelet Disorders
Hematologic Diseases
Anemia
Bone Marrow Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on August 23, 2016