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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 November 2016 |
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Main ID: |
NCT02967328 |
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Date of registration:
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16/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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RP% Measurement by FCM as a Diagnostic Test for ITP
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Scientific title:
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A Multi-Center Prospective Blind Study of RP% Measurement by Flow Cytometry in the Diagnosis of Primary Immune Thrombocytopenia |
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Date of first enrolment:
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November 2016 |
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Target sample size:
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500 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02967328 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Ming Hou, Dr. |
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Address:
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Telephone:
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+86-531-82169114 |
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Email:
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houming@medmail.com.cn |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Untreated adult patients of both gender between the ages of 18 and 75 years
2. Each participant showed a platelet count 60*10^9/L, with or without bleeding
manifestations
3. Thrombocytopenic disorders including autoimmune-mediated, aplastic (hypoplastic) or
chemotherapy-induced thrombocytopenia
Exclusion Criteria:
1. Received high-dose steroids or IVIG within 3 weeks prior to the test
2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine,
vincristine, vinblastine, etc) within 3 months prior to the test
3. Current HIV infection, hepatitis B virus or hepatitis C virus infections
4. Severe medical condition (liver and kidney function impairment). Unstable
cardiovascular disease or uncontrolled hypertension.
5. Patients who are deemed unsuitable for the study by the investigator
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Immune Thrombocytopenia
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Intervention(s)
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Other: RP% Measurement by FCM as a Diagnostic Test for ITP
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Primary Outcome(s)
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Total platelet count (RP%)
[Time Frame: The day upon enrollment]
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Secondary ID(s)
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ITP-Reticulated Platelets
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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