Clinical trial NCT04777435: Therapeutic Orientation Test in Thrombotic Microangiopathy
Official title: Therapeutic Orientation Test in Thrombotic Microangiopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thrombotic Micro-angiopathy
Keywords: Nephrology
Complement
Thrombotic micro-angiopathy
Diagnostic
Haemolytic and Uraemic Syndrome
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 100
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

TMA with:

* 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

Primary outcomes:
measure: Therapeutic orientation test sensitivity
timeFrame: Through study completion, an average of 3 years.
measure: Therapeutic orientation test specificity
timeFrame: Through study completion, an average of 3 years.
Secondary outcomes:
measure: Untreated test positive patients
timeFrame: Through study completion, an average of 3 years.
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Cabestany
country: France
facility: Site Médipôle Cabestany
city: Castelnau-le-Lez
country: France
facility: Centre Nephrocare Castelnau-le-Lez
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: CHU de Lille
city: Limoges
country: France
facility: CHU de Limoges
city: Marseille
country: France
facility: APHM-Hôpital de la Conception
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Nantes
country: France
facility: CHU de Nantes
city: Narbonne
country: France
facility: HPGN- Narbonne
city: Nice
country: France
facility: CHU de Nice
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: APHP-Hôpital Tenon
city: Paris
country: France
facility: Hôpital Paris Necker
city: Paris
country: France
facility: Hôpital Robert Debré
city: Perpignan
country: France
facility: CH de Perpignan
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rouen
country: France
facility: CHU de Rouen
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
References: