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

University of Cologne

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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