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Therapeutic Orientation Test in Thrombotic Microangiopathy

Not Applicable
Recruiting
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Therapeutic orientation test sensitivityThrough 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 specificityThrough 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
NameTimeMethod
Untreated test positive patientsThrough 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.

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

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CHU de Bordeaux
🇫🇷Bordeaux, France
COUZI Lionel, MD
Principal Investigator
HARAMBAT Jérôme, MD
Principal Investigator
DELMAS Muriel-Yahsou, MD
Sub Investigator

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