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. |
Register:
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ANZCTR |
Last refreshed on:
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28 February 2022 |
Main ID: |
ACTRN12614001073695 |
Date of registration:
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07/10/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Multi-centre, Observational Study of Patients with Microangiopathic Thrombocytopenia by the Asian-Pacific Microangiopathic Thrombocytopenia (APMAT) Network
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Scientific title:
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A Multi-centre, Observational Study by the Asian-Pacific Microangiopathic Thrombocytopenia (APMAT) Network To Determine The Clinical Characteristics, Laboratory Features, Treatments, and Clinical Outcomes in Patients with Microangiopathic Thrombocytopenia
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Date of first enrolment:
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01/01/2015 |
Target sample size:
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300 |
Recruitment status: |
Recruiting |
URL:
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https://anzctr.org.au/ACTRN12614001073695.aspx |
Study type:
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Observational |
Study design:
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Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Retrospective;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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China
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Hong Kong
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India
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Japan
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Korea, Republic Of
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Malaysia
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New Zealand
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Singapore
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Taiwan, Province Of China
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Thailand
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Contacts
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Name:
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Dr Jim Tiao
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Address:
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Perth Blood Institute,
Hollywood Specialist Centre
3/95 Monash Avenue
Nedlands
WA 6009
Australia |
Telephone:
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+61 93601319 |
Email:
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j.tiao@wacth.org |
Affiliation:
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Name:
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Prof Ross Baker
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Address:
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Perth Blood Institute,
Hollywood Specialist Centre
3/95 Monash Avenue
Nedlands
WA 6009
Australia |
Telephone:
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+61 892004904 |
Email:
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ross@aptin.org |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients presenting to a study centre and diagnosed with microangiopathic thrombocytopenia as defined by but not limited to anaemia, thrombocytopenia (<150 x10^9/L) and evidence of fragmented red blood cells (schistocytes) on blood film.
Exclusion criteria: Patients who have non-microangiopathic thrombocytopenia and/or thrombosis where an alternate diagnosis is likely.
Patients who are unable or unwilling to provide informed consent.
Age minimum:
1 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Blood - Other blood disorders
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Microangiopathic Thrombocytopenia; Microangiopathic Thrombocytopenia
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Intervention(s)
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This is an observational study of previously diagnosed and treated microangiopathic thrombocytopenia (MAT) patients. MAT is a rare collection of disorders caused by the formation of intravascular aggregates of platelets resulting in microcirculatory thrombosis, red blood cell destruction and vital end-organ damage. The study will collect clinical and laboratory data to assess the disease characteristics, laboratory features, treatment strategies employed, and clinical outcome. Each participant will be observed for 6 months once they are enrolled in the study.
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Primary Outcome(s)
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To determine laboratory features microangiopathic thrombocytopenia patients. Methods for analysis include standard coagulation tests and cell counts, flow cytometry, immunoassays, activity assays and/or genotyping. [Follow-up of patients: 6 months; Collection of data for all patients: Approx 18 months]
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To determine the clinical characteristics of microangiopathic thrombocytopenia including symptoms, potential precipitating factors, outcome, genetic, autoantibody and immune complex factors. Data will be collected by reviewing patients' medical records.[Follow-up of patients: 6 months; Collection of data for all patients: Approx 18 months]
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To determine the treatments given for microangiopathic thrombocytopenia. Data will be collected by reviewing patients' medical records.[Follow-up of patients: 6 months; Collection of data for all patients: Approx 18 months]
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Secondary Outcome(s)
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To assess the value of ADAMTS13 testing in predicting disease relapse. Immunoassays and activity assays will be performed on blood samples collected at enrolment and six months post-enrolment.[Follow-up of patients: 6 months;
Collection of data for all patients: Approx 18 months]
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To assess the value of ADAMTS13 genetic mutations in predicting disease relapse. Genotyping will be performed on blood samples collected at enrolment and six months post-enrolment.[Follow-up of patients: 6 months;
Collection of data for all patients: Approx 18 months]
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To establish a MAT Biobank for further testing of novel assays used for the diagnosis and scientific understanding of MAT.[18 months]
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To facilitate basic disease mechanism and translational clinical research.[3 years]
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Source(s) of Monetary Support
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Alexion Pharmaceuticals Australasia Pty Limited
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Takeda
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Australasian Society of Thrombosis and Haemostasis (ASTH)
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Ethics review
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Status: Approved
Approval date: 14/08/2014
Contact:
Hollywood Private Hospital Research Ethics Committee
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Status: Approved
Approval date: 08/05/2015
Contact:
Health and Disability Ethics Committees
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Status: Approved
Approval date: 05/02/2016
Contact:
Kementerian Keshihatan Malaysis
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Status: Approved
Approval date: 25/02/2016
Contact:
NEAF: Hunter New England Human Research Ethics Committee
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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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