NCT02373267

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)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 26, 2015

Status Verified

February 1, 2015

Enrollment Period

1.9 years

First QC Date

January 24, 2015

Last Update Submit

February 20, 2015

Conditions

Thrombotic Microangiopathies

Outcome Measures

Primary Outcomes (1)

  • relative incidences of different entities of TMA

    at baseline

Secondary Outcomes (1)

  • Mean value of ADAMTS13 activity and antigen measured at date of first diagnosis.

    at baseline

Other Outcomes (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

Interventions

TechnozymeBIOLOGICAL

determination of ADAMTS13 activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients with first history of TMA as patients with recurrent TMA or TMA in complete or partial remission are eligible for analysis

You may not qualify if:

  • Patients who received plasma intervention more than 3 weeks prior to screening must be excluded from the observational study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

* 2x 5 ml citrate blood * 2x 3 ml EDTA blood * 1x 5 ml lithium heparin blood * 1x 5 ml serum blood * 1x 3 ml stool * 1x 9 ml urine * 1x blood smear

MeSH Terms

Conditions

Thrombotic Microangiopathies

Condition Hierarchy (Ancestors)

ThrombocytopeniaBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

January 24, 2015

First Posted

February 26, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2019

Last Updated

February 26, 2015

Record last verified: 2015-02