A Multi-centre, Observational Study of Patients with Microangiopathic Thrombocytopenia by the Asian-Pacific Microangiopathic Thrombocytopenia (APMAT) Network

Not Applicable

Recruiting

• Conditions: Microangiopathic Thrombocytopenia; Blood - Other blood disorders

• Registration Number: ACTRN12614001073695
• Lead Sponsor: ASTH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-07
• Last Update Posted: 28 February 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;<br>Collection of data for all patients: Approx 18 months];To determine the treatments given for microangiopathic thrombocytopenia. Data will be collected by reviewing patients' medical records.[Follow-up of patients: 6 months;<br>Collection of data for all patients: Approx 18 months];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;<br>Collection of data for all patients: Approx 18 months]

Secondary Outcome Measures

Name	Time	Method
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;<br>Collection of data for all patients: Approx 18 months];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;<br>Collection of data for all patients: Approx 18 months];To establish a MAT Biobank for further testing of novel assays used for the diagnosis and scientific understanding of MAT.[18 months];To facilitate basic disease mechanism and translational clinical research.[3 years]