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Screening of TMA Patients für ADAMTS13 Activity (Adamscreen) (Adamscreen)

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ClinicalTrials.gov Identifier: NCT02373267
Recruitment Status : Unknown
Verified February 2015 by Dr. med. Brigitte Schneider, University of Cologne.
Recruitment status was:  Not yet recruiting
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. med. Brigitte Schneider, University of Cologne

Brief Summary:
Screening of TMA patients for ADAMTS13 activity and the description of systemic organ damage and/or organ failure in different entities of thrombotic microangiopathies (TMA)

Condition or disease Intervention/treatment
Thrombotic Microangiopathies Biological: Technozyme

Detailed Description:
This is a prospective diagnostic analysis enrolling 100 patients with clinically suspected thrombotic microangiopathy (TMA) on the basis of laboratory findings such as thrombocytopenia, Coombs negative haemolytic anemia with increased LDH and increased schistozytes. As a first step of differential diagnosis, patients are classified by determining ADAMTS13 activity and antigen concentration and also analyzing for Shigatoxin and Shigatoxin producing bacteria respectively. Primary objective is to determine the relative incidences of the three major entities i.e. aHUS, STEC-HUS and TTP considering distribution of age and gender as well. Mean value of ADAMTS13 activity and antigen measured at date of first diagnosis is considered to line out a threshold value for ADAMTS13 activity pronouncing clinical apparent TMA. Furthermore the present study intends to characterize clinical presentation, clinical course and outcome of different TMA forms particularly with regard to treatment procedures. Monitoring of how ADAMTS13 activity and antigen changes in the course of the disease and in response to treatment is of particular concern for this study. Family history and special clinical conditions should be noted identifying potential genetic predisposition and definite clinical triggers leading to disease manifestation.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening of TMA Patients for ADAMTS13 Activity and the Description of Systematic Organ Damage and/or Organ Failure in Different Entities of Thrombotic Microangiopathies (TMA)
Study Start Date : March 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2019

Intervention Details:
  • Biological: Technozyme
    determination of ADAMTS13 activity


Primary Outcome Measures :
  1. relative incidences of different entities of TMA [ Time Frame: at baseline ]

Secondary Outcome Measures :
  1. Mean value of ADAMTS13 activity and antigen measured at date of first diagnosis. [ Time Frame: at baseline ]

Other Outcome Measures:
  1. clinical presentation, clinical course and outcome of different TMA forms particularly with regard to treatment procedures. Monitoring of how ADAMTS13 activity and antigen changes in the course of the disease and in response to treatme [ Time Frame: at baseline and in course ]

Biospecimen Retention:   Samples Without DNA
  • 2x 5 ml citrate blood
  • 2x 3 ml EDTA blood
  • 1x 5 ml lithium heparin blood
  • 1x 5 ml serum blood
  • 1x 3 ml stool
  • 1x 9 ml urine
  • 1x blood smear


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients with a constellation of thrombocytopenia, Coombs negative hemolytic anaemia and clinical signs of ischaemic end organ damage or abdominal symptoms.
Criteria

Inclusion Criteria:

-Patients with first history of TMA as patients with recurrent TMA or TMA in complete or partial remission are eligible for analysis

Exclusion Criteria:

-Patients who received plasma intervention more than 3 weeks prior to screening must be excluded from the observational study

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Responsible Party: Dr. med. Brigitte Schneider, physician, University of Cologne
ClinicalTrials.gov Identifier: NCT02373267    
Other Study ID Numbers: 41-14
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases