- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02373267
Screening of TMA Patients für ADAMTS13 Activity (Adamscreen) (Adamscreen)
February 20, 2015 updated by: Dr. med. Brigitte Schneider, University of Cologne
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)
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)
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
100
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
relative incidences of different entities of TMA
Time Frame: at baseline
|
at baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean value of ADAMTS13 activity and antigen measured at date of first diagnosis.
Time Frame: at baseline
|
at baseline
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
at baseline and in course
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
February 1, 2017
Study Completion (Anticipated)
February 1, 2019
Study Registration Dates
First Submitted
January 24, 2015
First Submitted That Met QC Criteria
February 20, 2015
First Posted (Estimate)
February 26, 2015
Study Record Updates
Last Update Posted (Estimate)
February 26, 2015
Last Update Submitted That Met QC Criteria
February 20, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 41-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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