Thrombotic MicroangiopathiesAdamscreenNCT02373267
Screening of TMA Patients für ADAMTS13 Activity (Adamscreen)
An observational study of Thrombotic Microangiopathies, run by University of Cologne.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thrombotic Microangiopathies
- What is being tested?
- Technozyme
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with a constellation of thrombocytopenia, Coombs negative hemolytic anaemia and clinical signs of ischaemic end organ damage or abdominal symptoms.
Who may be able to join
- -Patients with first history of TMA as patients with recurrent TMA or TMA in complete or partial remission are eligible for analysis
Who cannot join
- -Patients who received plasma intervention more than 3 weeks prior to screening must be excluded from the observational study
About this study
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)
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)
Read the 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
- Being tested
- Technozyme
- Medical subject headings
- Thrombotic Microangiopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TechnozymeBiological
determination of ADAMTS13 activity
What is being measured
The primary outcome is the main question the study is designed to answer.
relative incidences of different entities of TMA
Measured: at baseline
Secondary outcomes (1)
Mean value of ADAMTS13 activity and antigen measured at date of first diagnosis.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombotic MicroangiopathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Brigitte Schneider, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373267
- Sponsor's protocol ID
- 41-14
- Acronym
- Adamscreen
- Status last verified
- Feb 2015
- First submitted
- 24 Jan 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02373267
- Acronym / sponsor ID
- Adamscreen / 41-14
- Conditions
- Thrombotic Microangiopathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a constellation of thrombocytopenia, Coombs negative hemolytic anaemia and clinical signs of ischaemic end organ damage or abdominal symptoms.
Key inclusion criteria (1 listed)
- -Patients with first history of TMA as patients with recurrent TMA or TMA in complete or partial remission are eligible for analysis
Key exclusion criteria (1 listed)
- -Patients who received plasma intervention more than 3 weeks prior to screening must be excluded from the observational study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technozymedetermination of ADAMTS13 activity | Biological | – |
Primary outcome
relative incidences of different entities of TMA
Time frame: at baseline
1 secondary outcome
Mean value of ADAMTS13 activity and antigen measured at date of first diagnosis.
Time frame: at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombotic Microangiopathies, run by University of Cologne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative incidences of different entities of TMA (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2015.