Therapeutic Orientation Test in Thrombotic Microangiopathy
- Conditions
- Thrombotic Micro-angiopathy
- Registration Number
- NCT04777435
- Lead Sponsor
- University Hospital, Montpellier
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
TMA with:
- mechanic haemolytic anemia, undetectable haptoglobin, LDH>1.5*LNS
- thrombopenia
- acute kidney injury TMA on native kidney or in post-transplantation.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Therapeutic orientation test sensitivity 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 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 Outcome Measures
Name Time Method Untreated test positive patients Through study completion, an average of 3 years. The proportion of patients with positive test but untreated by Eculizumab, and who therefore could have benefited from treatment.
Related Research Topics
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Trial Locations
- Locations (20)
CHU de Bordeaux
🇫🇷Bordeaux, France
Site Médipôle Cabestany
🇫🇷Cabestany, France
Centre Nephrocare Castelnau-le-Lez
🇫🇷Castelnau-le-Lez, France
CHU de Grenoble
🇫🇷Grenoble, France
CHU de Lille
🇫🇷Lille, France
CHU de Limoges
🇫🇷Limoges, France
APHM-Hôpital de la Conception
🇫🇷Marseille, France
Montpellier University Hospital
🇫🇷Montpellier, France
CHU de Nantes
🇫🇷Nantes, France
HPGN- Narbonne
🇫🇷Narbonne, France
Scroll for more (10 remaining)CHU de Bordeaux🇫🇷Bordeaux, FranceCOUZI Lionel, MDPrincipal InvestigatorHARAMBAT Jérôme, MDPrincipal InvestigatorDELMAS Muriel-Yahsou, MDSub Investigator