Screening of TMA Patients für ADAMTS13 Activity (Adamscreen)

NCT ID: NCT02373267

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2019-02-28

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)

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.

Conditions

Thrombotic Microangiopathies

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Technozyme

determination of ADAMTS13 activity

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Brigitte Schneider

physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

41-14

Identifier Type: -

Identifier Source: org_study_id