Trial document




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  DRKS00006083

Trial Description

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Title

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

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Trial Acronym

CESAR

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Thrombotic microangiopathies (TMA) lead to occlusion of the tiny capillaries in internal organs through blood-clotting. As a result, blood flow through the organs decreases and serious damage, especially in the kidneys, may occur. For the origination of a thrombotic microangiopathy several causes may be responsible, e.g. infection with Shigatoxin-producing bacteria, uncontrolled activation of the complement system which is a part of the innate immune system or an increased tendency to thrombosis due to a malfunction of blood clotting. Objective of the study is to determine how frequent the different causes for thrombotic microangiopathies are relative to each other. By analysing blood and stool samples the different causes will be distinguished. In addition, it will be analysed which symptoms and laboratory values show a relationship with these different causes. For that purpose, the blood and stool diagnostic which is carried out in clinical routine will be observed and evaluated.

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Brief Summary in Scientific Language

Primary objective is to determine the 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), respectively.
These three thrombotic microangiopathies (TMA) TTP, STEC-HUS and aHUS are difficult to distinguish clinically. This requires a special laboratory diagnostic, i.e. measuring the activity of the metalloprotease ADAMTS13 and screening for presence of STEC bacteria and shigatoxin in stool samples. Both analyses and their results will be evaluated.
The incidence of STEC-HUS, aHUS and TTP, respectively, for clinically suspected thrombotic microangiopathies is not known yet.
Secondary objective is to compare clinical symptoms and laboratory parameters between patients with STEC-HUS, aHUS and TTP.
All three diseases are life-threatening or disabling. Since different effective therapies are available but laboratory diagnostics require some time before delivering conclusive results, further knowledge about clinical diagnostic features and incidence are important.

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Organizational Data

  •   DRKS00006083
  •   2014/04/23
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  •   no
  •   Approved
  •   13067, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

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Health Condition or Problem studied

  •   D59.3 -  Haemolytic-uraemic syndrome
  •   M31.1 -  Thrombotic microangiopathy
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Interventions/Observational Groups

  •   evaluation of routine blood and stool diagnostic
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/04/25
  •   300
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional 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

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Exclusion Criteria

plasma intervention before blood sampling, antibiotic therapy before stool sampling

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Addresses

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    • Alexion Pharma Germany GmbH
    • Landsberger Straße 300
    • 80687  München
    • Germany
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    • Alexion Pharma Germany GmbH
    • Mr.  Dr.  Michael  Jeglitsch 
    • Landsberger Straße 300
    • 80687  München
    • Germany
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    • Alexion Pharma Germany GmbH
    • Mr.  Dr.  Michael  Jeglitsch 
    • Landsberger Straße 300
    • 80687  München
    • Germany
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Sources of Monetary or Material Support

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    • Alexion Pharma Germany GmbH
    • Landsberger Straße 300
    • 80687  München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/03/29
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.