Study of 'Vascular Competence' Profile… | Clinical Trial

Key information

Conditions

Hemolytic Uremic Syndrome Anemia Anemia, Hemolytic Blood Platelet Disorders Cytopenia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemolytic-Uremic Syndrome Kidney Diseases Male Urogenital Diseases Thrombocytopenia Thrombotic Microangiopathies Uremia Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, France

About this study

The Hemolytic Uremic Syndrome (HUS) is a rare thrombotic microangiopathy (TMA), affecting both children and adults. HUS is characterized by the abnormal occurrence of diffuse thrombosis in the microcirculation resulting in the occurrence of ischemic events affecting especially the kidneys and is associated with hemolytic anemia.Its prognosis is severe, with a mortality of 1% in children, 10% in adults and the occurrence of renal failure in 50% of cases.In its typical form, HUS occurs in the aftermath of a diarrheic intestinal infection by bacteria which produce a Shiga toxin. In its unusual shape, which affects both children and adults, there are genetic abnormalities alternate way of regulating complement proteins explaining frequent relapses.One of the major problems encountered in the management of HUS is the absence of reliable marker of treatment response or relapse; conventional hematological markers being too insensitive to judge therapeutic efficacy or identify early relapse. Data from the literature suggest that the endothelial cell is a major target of this syndrome. Our hypothesis is that an initial micro-endothelial activation plays a critical role in the initiation and / or relapse of the disease through the sudden release of high molecular weight ultralarge von Willebrand factor (UL-vWHf) and procoagulant endothelial microparticles.The main objective of this study is to define a "vascular competence" profile in a population of patients with typical or atypical HUS; both in the acute phase and in remission of the disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with a clinical diagnosis of typical or atypical HUS in acute phase

Exclusion criteria

Patient with positive serological screening test for infection with the HIV.
Patients with a history of cancer.
Patients who have undergone organ transplantation or bone marrow.
Patient with a vivid picture of autoimmune thrombotic thrombocytopenic purpura

Treatment and study plan

extra blood draw samples

Biological

Primary outcomes

number of circulating endothelial cells (CECs) and endothelial progenitor cells (EPCs)

Time frame: 36 months
number of endothelial progenitor cells (EPCs)

Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: SHU

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2023
First posted: Sep 19, 2016
Registry last updated: Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed