Therapeutic Orientation Test in Thrombotic Microangiopathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 57
- Primary Endpoint
- Therapeutic orientation test sensitivity
Study Overview
Brief Summary
Haemolytic and Uraemic Syndrome (HUS) is a serious disease requiring rapid diagnosis and management. The atypical HUS diagnosis has been greatly improved by anti-CS antibody (Eculizumab) wich block alternative complement pathway activation. To rise treatment success, Eculizumab introduction should be as early as possible. In some secondary HUS (infection, drugs…) complement is also involved as "second-hit".
To date, there is no tool to confirm complement involvement in a HUS at diagnosis stage. This study suggest to evaluate a therapeutic orientation test, in order to determine the complement implication in HUS diagnosis. The test evaluates the complement deposits on endothelial cell surface in vitro, compared to a normal human serum.
In order to determine the test performance, first the positive or negative results will be compared to the HUS clinical evolution, treated or not by the clinician with Eculizumab. Second, the test results will be compared to the presence of alternative complement pathway regulation abnormalities.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- — to 90 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •mechanic haemolytic anemia, undetectable haptoglobin, LDH>1.5*LNS
- •thrombopenia
- •acute kidney injury TMA on native kidney or in post-transplantation.
Exclusion Criteria
- •DIVC patients
- •plasma exchange during 1 month before sample collection
- •treatment by Eculizumab before sample collection
- •no consent
- •not beneficiary of a social security
- •pregnancy or breastfeeding
- •patient Under guardianship
Arms & Interventions
Patients with Thrombotic micro-angiopathy
Intervention: Therapeutic orientation test for TMA (Diagnostic Test)
Outcomes
Primary Outcomes
Therapeutic orientation test sensitivity
Time Frame: Through study completion, an average of 3 years.
The proportion of patients testing positive among those receiving a relevant Eculizumab treatment ( TMA resolution with treatment or presence of abnormalities in alternative complement pathway.
Therapeutic orientation test specificity
Time Frame: Through study completion, an average of 3 years.
The proportion of patients testing negative among patients who did not receive Eculizumab treatment.(TMA resolution without treatment or therapeutic failure with Eculizumab).
Secondary Outcomes
- Untreated test positive patients(Through study completion, an average of 3 years.)