Screening of TMA Patients für ADAMTS13 Activity (Adamscreen)

• Sponsor: University of Cologne (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02373267
• Collaborator: (none)
• Enrollment: 100
• Duration (Months): 47.1

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Anticipated 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: Mar 1, 2015
• Anticipated Primary Completion Date: Feb 1, 2017
• Anticipated Study Completion Date: Feb 1, 2019

Outcome Measures

Primary Outcome Measures

1. relative incidences of different entities of TMA [at baseline]

Secondary Outcome Measures

1. Mean value of ADAMTS13 activity and antigen measured at date of first diagnosis. [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 [at baseline and in course]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Cologne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. med. Brigitte Schneider, physician, University of Cologne
• ClinicalTrials.gov Identifier: NCT02373267
• Other Study ID Numbers: 41-14
• First Posted: Feb 26, 2015
• Last Update Posted: Feb 26, 2015
• Last Verified: Feb 1, 2015

• Additional relevant MeSH terms: Thrombotic Microangiopathies

Study Results

No Results Posted as of Feb 26, 2015