Cross-sectional Evaluation of clinical symptoms and epidemiologic parameters in patients with TMA, differentiated by laboratory param-eters (CESAR)

• Conditions: D59.3; M31.1; Haemolytic-uraemic syndrome; Thrombotic microangiopathy

• Registration Number: DRKS00006083
• Lead Sponsor: Alexion Pharma Germany GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-23
• Study Completion: 2017-03-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

1. microangiopathic hemolytic anaemia, 2. thrombocytopenia: thrombocytes < 150 x 10´`9/l or thrombocytes decreased by more than 25% during one week, 3. One of the following: neurological symptoms, renal dysfunction, gastrointestinal symptoms

Exclusion Criteria

plasma intervention before blood sampling, antibiotic therapy before stool sampling

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
relative incidence of STEC-HUS (hemolytic uremic syndrome caused by Shigatoxin-producing E.coli serotypes), aHUS (atypical hemolytic uremic syndrome), and TTP (thrombotic thrombocytopenic purpura) through measuring ADAMTS13 activity and screening for shigatoxin-producing bacteria and shigatoxin.

Secondary Outcome Measures

Name	Time	Method
comparison clinical symptoms and routine blood parameter for TTP, aHUS and STEC-HUS.